[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dominik Paul Modest\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100439939","phase-3-post-resectionablation-chemotherapy-in-patients-with-metastatic-colorectal-cancer-fire-9---port--aio-krk-0418-100439939",false,"NCT05008809","Post-resection\u002FAblation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT \u002F AIO-KRK-0418)","Post-resection\u002FAblation Chemotherapy in Patients With Metastatic Colorectal Cancer Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy of Active Post-resection\u002FAblation Therapy in Patients With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Patient's signed informed consent.\n2. Patient's age ≥18 years at the time of signing the informed consent.\n3. Histologically confirmed adenocarcinoma of the colon or rectum.\n4. Resected (R0 or R1) and\u002For effectively treated metastases (all techniques allowed) of colorectal cancer within 3-10 weeks before randomization (earlier randomisation allowed if at least 3 weeks interval between intervention and treatment start is guaranteed) AND resected primary tumor (synchronous or metachronous). In cases of synchronous metastases the interval of 3-10 weeks might be calculated following the removal of the primary tumor if this intervention was the last to address all tumor lesions.\n5. Absence of significant active wound healing complications (if applicable) at randomization. Resolved wound healing complications after resection\u002Fablation are acceptable for inclusion into the trial.\n6. No radiographic evidence of active metastatic disease at study entry in a CT and\u002For MRI scan not older than 10 weeks prior randomization. Pre-surgery\u002Fablation images are eligible for the study if all lesions have been addressed in the interval.\n7. ECOG performance status 0-2.\n8. Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results:\n\n   * Absolute neutrophil count \\>= 1.5 x 109\u002FL (1500\u002FµL)\n   * Hemoglobin ≥ 80 g\u002FL (8 g\u002FdL)\n   * Platelet count ≥ 100 x109\u002FL (100000\u002FµL) without transfusion\n   * Total serum bilirubin of ≤ 1.5 x upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST\u002FGOT) ≤ 3.0 × ULN.\n   * Calculated glomerular filtration rate (GFR) according to Cockcroft-Gault formula or according to MDRD ≥ 50 mL\u002Fmin or serum creatinine ≤ 1.5 x ULN\n9. Patients without anticoagulation need to present with an INR \\\u003C 1.5 x ULN and PTT \\\u003C 1.5 x ULN. Patient with prophylactic or therapeutic anticoagulation are allowed into the trial.\n10. Proficient fluorouracil metabolism as defined:\n\n    1. Prior treatment with 5-FU or capecitabine without unusual toxicity or\n    2. If tested, normal DPD deficiency test according to the standard of the study site or\n    3. If tested, in patients with DPD deficiency test with a CPIC activity score of 1.0-1.5 fluoropyrimidine\u002Fcapecitabine dosage should be reduced by 50%\n11. For women of childbearing potential (WOCBP): negative pregnancy test within 14 days before randomization and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 9 months after the last dose of Oxaliplatin or for at least 6 months after the last dose of all other study treatment.\n\nA woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male partner's sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nFor men: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 6 months after the last dose of study treatment. Men must refrain from donating sperm during this same period.\n\nExclusion Criteria:\n\n1. Treatment of metastases greater than 3 cm with radio-frequency\u002Fmicrowave ablation within 24 months prior to study entry if applicable.\n2. Treatment of metastases greater than 5 cm with radiation (stereotactic\u002F brachytherapy) within 24 months prior to study entry if applicable.\n3. Any previous systemic therapy is allowed for inclusion into the trial. However, if previous oxaliplatin-containing chemotherapy at any time for metastatic or localized disease was carried out, the inclusion into the trial is permitted under the condition, that\n\n   1. A total duration of oxaliplatin-based therapy of six months (i.e. 12 cycles of FOLFOX \u002F FOLFOXIRI or 8 cycles CAPOX) is not exceeded - including therapy within the FIRE-9\u002FPORT trial\n   2. If already more than three months of oxaliplatin-based therapy (i.e. \\>6 cycles of FOLFOX \u002F FOLFOXIRI or \\>4 cycles CAPOX) was used, the study therapy should be started with an irinotecan-based regimen (i.e. FOLFIRI or FOLFOXIRI) However, in the case of FOLFOXIRI therapy in the trial, the above mention regulation concerning the total dosing of oxaliplatin still applies (i.e. 12 cycles of FOLFOX \u002F FOLFOXIRI or 8 cycles CAPOX should not be exceeded - including therapy within the FIRE-9\u002FPORT trial).\n4. New York Heart Association Class III or greater heart failure by clinical judgement.\n5. Myocardial infarction within 6 months prior to randomization; percutaneous transluminal coronary angioplasty (PTCA) with or without stenting within 6 months prior to randomization.\n6. Unstable angina pectoris.\n7. Unstable cardiac arrhythmia \\> grade 2 NCI CTCAE despite anti-arrhythmic therapy.\n8. Ongoing toxicities \\> grade 2 NCI CTCAE\n9. Active uncontrolled infection by investigator's perspective.\n10. Severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture.\n11. Known hypersensitivity to 5-FU, folinic acid, irinotecan, oxaliplatin or capecitabine or to any of the other excipients listed in section 6.1 of the corresponding SmPC.\n12. Recent or concomitant treatment with brivudine.\n13. Peripheral sensitive neuropathy with functional impairment (\\> grade 1 acc. to CTCAE version 5.0 (see appendix 2)).\n14. Inflammatory bowel disease and\u002For bowel obstruction.\n15. Simultaneous application of Johannis herbs preparations.\n16. Pernicious or other megaloblastic anemia caused by vitamin B12 deficiency.\n17. Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to randomization or at least to intended treatment start, or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure.\n18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n19. Medical history of malignant disease other than mCRC with the following exceptions:\n\n    * patients who have been disease-free for at least three years before randomization\n    * patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer\n    * patients with any treated or untreated malignant disease that is associated with a 5-year survival prognosis of ≥ 90% and does not require active therapy\n20. Known alcohol or drug abuse.\n21. Pregnant or breastfeeding females.\n22. Participation in a clinical trial or experimental drug treatment within 28 days prior to potential inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment prior to potential inclusion in the clinical trial, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial.\n23. Patients depending on Sponsor, investigator or study site.\n24. Suspected SARS-CoV-2 infection with or without symptoms (evaluation according to local policy in respective center with respect to actual status of pandemic and with reference to the policy that would apply to patients with similar therapy outside the trial). This may include assessment of vaccination status, anamnesis, physical examination and potentially antigen and\u002For PCR testing.\n25. Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n26. Limited legal capacity.\n27. Concomitant administration of strong CYP3A4 and\u002For UGT1A1 inducers (e.g. Rifampicin, Carbamazepin, Phenobarbital, Phenytoin or Apalutamid).\n28. Planned inoculation\u002Fvaccination with a live vaccine during treatment with Oxaliplatin and\u002For Irinotecan, and until 6 months after treatment with Irinotecan.","ALL","18 Years",{"count":19,"type":20},507,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with metastatic colorectal cancer after definite interventional therapy of all lesions are randomized in a 2:1 fashion (favoring active therapy) to investigate the efficacy, patient reported quality of life and safety of mFOLFOXIRI\u002FmFOLFOX-6 as additive treatment (Arm A) versus active follow-up\u002Fsurveillance (Arm B).",[26],"Colorectal Cancer",[26],"RECRUITING","2025-12-05",{"date":31,"type":32},"2025-12-12","ACTUAL",{"date":34,"type":32},"2021-12-06",{"date":36,"type":20},"2030-11",{"name":38,"class":39},"Dominik Paul Modest","OTHER",79,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100585216","phase-3-pre-operative-treatment-in-resectable-colon-cancer-100585216","NCT06899477","Pre-Operative Treatment in REseCTable COlon CanceR","Pre-Operative Treatment in REseCTable COlon CanceR (PROTECTOR\u002FFIRE-10; AIO-KRK-0620; IAG-VO-0323) Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy Preoperative Systemic Therapy in Advanced Colon Cancer","Inclusion Criteria:\n\n1. Patient's signed informed consent.\n2. Patient's age ≥18 years at the time of signing the informed consent.\n3. Histologically confirmed adenocarcinoma of the colon or upper rectum.\n4. Confirmed mismatch-repair proficient and\u002For microsatellite stable tumor. Both Immunohistochemistry and PCR can be used for diagnosis.\n5. Intent for curative surgery\n6. Predicted T3 or T4 stage and or nodal positivity (N+) in a computed tomography and\u002For magnetic resonance imaging scan of the abdomen\u002Fpelvis as assessed by the local study team.\n\n   * T3-4 defined as invasion of surrounding tissue structures or organs\n   * N+ defined as regional lymph node(s) without fat hilus and short axis diameter of ≥1 cm\n7. Absence of clear distant metastases assessed by the investigator based on respective routine evaluations within 6 weeks prior to inclusion into the trial (preferred: computed tomography of thorax and abdomen. Alternatively magnetic resonance images, sonography and x-rays might be used for assessment).\n8. Absence of significant active wound healing including severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture\n9. ECOG performance status 0-2.\n10. Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results:\n\n    * Absolute neutrophil count ≥ 1.5 x 109\u002FL (1,500\u002FµL)\n    * Hemoglobin ≥ 80 g\u002FL (8 g\u002FdL) with or without transfusion\n    * Platelet count ≥ 100 x109\u002FL (100,000\u002FµL) without transfusion\n    * Total serum bilirubin of ≤ 1.5 x upper limit of normal (ULN)\n    * Aspartate aminotransferase (AST\u002FGOT) ≤ 3.0 × ULN.\n    * Calculated glomerular filtration rate (GFR) according to Cockcroft-Gault formula or according to MDRD ≥ 50 mL\u002Fmin or serum creatinine ≤ 1.5 x ULN\n11. Patients without anticoagulation need to present with an INR \\\u003C 1.5 x ULN and PTT \\\u003C 1.5 x ULN. Patient with prophylactic or therapeutic anticoagulation are allowed into the trial.\n12. Proficient fluorouracil metabolism as defined:\n\n    1. Prior treatment with 5-FU or capecitabine without unusal toxicity or\n    2. If tested, normal DPD deficiency test according to the standard of the study site or\n    3. If tested, in patients with DPD deficiency test with a CPIC activity score of 1.0-1.5 fluoropyrimidine dosage should be reduced by 50%\n13. For women of childbearing potential (WOCBP): negative pregnancy test within 7 days before treatment initiation and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the last dose of study treatment.\n\nA woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male partner's sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nFor men: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 6 months after the last dose of study treatment. Men must refrain from donating sperm during this same period.\n\nWith pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of study medication to avoid exposing the embryo.\n\nExclusion Criteria:\n\n1. Ileus or directly imminent ileus as assessed by the local study team. Patients with treated and resolved ileus are allowed into the trial.\n2. Previous chemotherapy for colorectal cancer of any stage\n3. New York Heart Association Class III or greater heart failure by clinical judgement.\n4. Myocardial infarction within 6 months prior to randomization; percutaneous transluminal coronary angioplasty (PTCA) with or without stenting within 6 months prior to randomization.\n5. Unstable angina pectoris.\n6. Unstable cardiac arrhythmia \\> grade 2 NCI CTCAE despite anti-arrhythmic therapy.\n7. Ongoing toxicities \\> grade 2 NCI CTCAE, in particular peripheral neuropathy.\n8. Active uncontrolled infection by investigator's perspective.\n9. Known hypersensitivity to 5-FU, folinic acid, capecitabine, irinotecan or oxaliplatin or to any of the other excipients listed in section 6.1 of the corresponding SmPC.\n10. Recent or concomitant treatment with brivudine.\n11. Peripheral sensitive neuropathy with functional impairment (\\> grade 1 acc. to CTCAE version 5.0 (see appendix 2)).\n12. Simultaneous application of St. John's Wort preparations.\n13. Pernicious or other megaloblastic anemia caused by vitamin B12 deficiency.\n14. Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to randomization that may interfere with systemic therapy as judged by the investigator.\n15. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications, including but not limited to:\n\n    * Simultaneous application of live vaccines during treatment with irinotecan and for at least 6 months after the last dose.\n    * 5-FU must not be given in combination with brivudin, sorivudin and analogues to patients homozygous for DPD and patients known with completely missing DPD activity.\n    * Severe diarrhoea.\n16. Medical history of malignant disease other than colorectal cancer with the following exceptions:\n\n    * patients who have been disease-free for at least three years before randomization\n    * patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer\n    * patients with any treated or untreated malignant disease that is associated with a 5-year survival prognosis of ≥ 90% and does not require active therapy\n17. Known alcohol or drug abuse.\n18. Pregnant or breastfeeding females.\n19. Participation in a clinical trial or experimental drug treatment within 28 days prior to potential inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment prior to potential inclusion in the clinical trial, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial.\n20. Patients depended on Sponsor, investigator or study site.\n21. Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n22. Limited legal capacity","120 Years",{"count":50,"type":20},714,[23],"This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with advanced colon cancer, including the upper third of the rectum, clinically staged cT3-4 and or cN+ (defined as lymph nodes with short axis of at least 1cm) are randomized in a 2:1 fashion (favoring preoperative therapy= Arm A) to investigate the efficacy, patient reported quality of life and safety of preoperative mFOLFOXIRI or mFOLFOX-6 or CAPOX followed by surgery versus the standard of care algorithm (surgery followed by stage-guided adjuvant therapy as recommended by the local multidisciplinary tumor board (Arm B)).",[54,55,56],"Colo-rectal Cancer","Colon Cancer","Colon Carcinoma",[58,59,60,61,62],"colo-rectal cancer","colon","neoadjuvant","upper rectum","pre-operative","NOT_YET_RECRUITING","2025-03-21",{"date":66,"type":32},"2025-03-28",{"date":68,"type":20},"2025-04",{"date":70,"type":20},"2035-04",{"name":38,"class":39},28,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100439810","phase-2-trifluridine-tipiracil-plus-panitumumab-versus-trifluridine-tipiracil-plus-bevacizumab-as-first-line-treatment-of-metastatic-colorectal-cancer-100439810","NCT05007132","Trifluridine\u002F Tipiracil Plus Panitumumab Versus Trifluridine\u002F Tipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer","Prospective, Randomized, Open, Multicenter Phase II Trial to Investigate the Efficacy of Trifluridine\u002FTipiracil Plus Panitumumab Versus Trifluridine\u002FTipiracil Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer: FIRE-8; AIO-KRK\u002FYMO-0519","Inclusion Criteria:\n\n1. Patient's signed informed consent\n2. Patients ≥ 18 years at the time of signing the informed consent\n3. Histologically confirmed adenocarcinoma of the colon or rectum\n4. Metastatic colorectal cancer (mCRC) with at least one measurable lesion according to RECIST 1.1 in a computed tomography (CT) or magnetic resonance imaging (MRI) scan performed within 5 weeks prior to randomisation\n5. Metastases are primarily unresectable or patient is unable\u002Funwilling to undergo surgery\n6. RAS (Rat Sarcoma) wild-type (Kirsten rat sarcoma (KRAS), exons 2, 3, 4 and Neuroblastoma RAS viral oncogene homologue (NRAS), exons 2, 3, 4) mCRC, proven in the primary tumor or metastasis. The RAS mutational status must be determined by means of a validated test method.\n7. Patient is not eligible to undergo combination chemotherapy according to investigator's assessment or unwilling to undergo combination chemotherapy.\n8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n9. Adequate bone marrow, hepatic and renal organ function, defined by the following laboratory test results:\n\n   * Absolute neutrophil count ≥ 1.5 x 109\u002FL (1500\u002FμL)\n   * Hemoglobin ≥ 80 g\u002FL (8 g\u002FdL)\n   * Platelet count ≥ 75 x109\u002FL (75,000\u002FμL) without transfusion\n   * Total serum bilirubin of ≤ 1.5 x upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST\u002FGOT) and alanine aminotransferase (ALT\u002FGPT) ≤ 2.5 × ULN; if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤ 5 × ULN\n   * Calculated glomerular filtration rate (GFR) according to Cockcroft - Gault formula or according to MDRD formula ≥ 30 mL\u002Fmin or serum creatinine ≤ 1.5 x ULN\n   * Urine dipstick for proteinuria \\\u003C 2+ (within 14 days prior to randomisation), unless a subsequent 24-hour urine collection demonstrates \\\u003C 1 g of protein in 24 hours.\n10. Patients without anticoagulation need to present with an INR \\\u003C1.5 x ULN and partial thromboplastin time (PTT) \\\u003C1.5 x ULN. Patients with anticoagulation may be enrolled if the patient receives the medication at a stable dose for at least 2 weeks before randomisation and provided that international normalized ratio (INR) and PTT are \\\u003C1.5 x ULN..\n11. For females of childbearing potential (FCBP): negative pregnancy test within 14 days before randomisation and agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for at least 6 months after the last dose of study treatment.\n\n    A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male partner's sterilization, hormonal contraceptives that inhibit ovulation supplemented with a barrier method, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n12. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C1% per year during the treatment period and for 6 months after the last dose of study treatment. In this regard, double barrier methods are not considered to have a failure rate of \\\u003C 1%. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 6 months after the last dose of study medication to avoid exposing the embryo. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Prior systemic therapy of metastatic disease. Note: Prior adjuvant chemotherapy is permitted, if completed \\> 3 months prior to randomisation. Multimodal treatment of rectal cancer is not considered antimetastatic therapy and does not preclude study participation\n2. Known brain metastasis. In case of symptoms that are suggestive of brain metastasis, brain metastasis has to be ruled out by means of cranial CT\u002FMRI.\n3. Significant cardiovascular disease such as: New York Heart Association Class III or greater heart failure; myocardial infarction within 6 months prior to randomisation; balloon angioplasty (PTCA) with or without stenting within 6 months prior to randomisation; despite anti-arrhythmic therapy unstable cardiac arrhythmia \\> grade 2 NCI CTCAE; unstable angina pectoris\n4. Transient ischaemic attack or cerebrovascular accident within 6 months prior to randomization, history of cerebral or aortic aneurysm or dissection\n5. Medical history of deep vein thrombosis or pulmonary embolism within 6 months prior to randomisation or medical history of recurrent thromboembolic events (\\> 1 episode of deep vein thrombosis, pulmonary embolism, peripheral embolism) within the last 2 years.\n6. Severe bleeding event within the last 6 months before randomisation (except tumor bleeding surgically treated by tumor resection)\n7. Evidence of bleeding diathesis or significant coagulopathy\n8. Uncontrolled hypertension defined as systolic blood pressure ≥160 mm Hg and\u002For diastolic ≥ 100 mm Hg under antihypertensive medication\n9. Severe chronic non-healing wounds, ulcerous lesions or untreated bone fracture.\n10. History of abdominal or tracheoesophageal fistula or gastrointestinal perforation, or intra-abdominal abscess -unrelated to surgery- within 6 months prior to randomisation.\n11. Acute or subacute bowel obstruction, active chronic inflammatory bowel disease or chronic diarrhea\n12. History of keratitis, ulcerative keratitis or severe dry eye.\n13. Hypersensitivity to trifluridine\u002Ftipiracil or panitumumab or bevacizumab or any of the excipients, known hypersensitivity to Chinese hamster ovary cell products, known hypersensitivity to human or humanized antibodies\n14. Current or recent (within 10 days of randomisation) use of or anticipated need for continuous treatment during study treatment with acetylsalicylic acid \\> 325 mg\u002Fday or treatment with dipyramidole, ticlopidine \\> 2 x 250 mg\u002Fday, clopidogrel \\> 75 mg\u002Fday, and cilostazol. Combination of these drugs are not allowed.\n15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomisation, or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 28 days prior to randomisation or anticipation of need for major surgical procedure during the course of the study or non-recovery from side effects of any such procedure\n16. Core biopsy or other minor surgical procedure, excluding placement of a vascular access devices, within 3 days prior to the first dose of bevacizumab\n17. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis\u002Finterstitial pneumonia, or idiopathic pneumonitis\u002Finterstitial pneumonia, or evidence of active pneumonitis or pulmonary fibrosis on screening chest imaging\n18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n19. Medical history of other malignant disease than mCRC with the following exceptions:\n\n    * patients who have been disease-free for at least three years before randomisation\n    * patients with adequately treated and completely resected basal cell or squamous cell skin cancer, in situ cervical, breast or prostate cancer, stage I uterine cancer\n    * patients with any treated or untreated malignant disease that is associated with a 5 year survival prognosis of ≥90% and does not require active therapy\n20. Known alcohol or drug abuse\n21. Pregnant or breastfeeding females\n22. Participation in a clinical trial or experimental drug treatment within 28 days prior to inclusion in the clinical trial or within a period of 5 half-lives of the substances administered in a clinical trial or during an experimental drug treatment prior to inclusion in the clinical trial, depending on which period is longest, or simultaneous participation in another clinical trial while taking part in this clinical trial.\n23. Patient committed to an institution by virtue of an order issued either by the judicial or the administrative authorities\n24. Patient possibly dependent from the investigator including the spouse, children and close relatives of any investigator\n25. Limited legal capacity",{"count":81,"type":20},153,[83],"PHASE2","FIRE-8 is a prospective, randomized, open label, multicenter phase II clinical trial. To evaluate the effecacy of trifluridine \u002F tipiracil and panitumumab (Arm A) compared to trifluridine \u002F tipiracil and bevacizumab (Arm B), participants will be randomly assigned to either Arm A or Arm B for the treatment of metastatic colorectal cancer.\n\nThe primary objectives of this study is to compare the effecacy of treatment with trifluridine \u002F tipiracil plus panitumumab versus trifluridine \u002F tipiracil plus bevacizumab.",[86],"Metastatic Colorectal Cancer",[86],"2024-02-14",{"date":90,"type":32},"2024-02-15",{"date":92,"type":32},"2021-12-17",{"date":94,"type":20},"2032-12",{"name":38,"class":39},1,""]