[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-malignant-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-malignant-neoplasm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100420005","phase-2-study-evaluating-the-tailored-management-of-locally-advanced-rectal-carcinoma-100420005",false,"NCT04749108","Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma","Multicentric Phase II-III Study Evaluating the Tailored Management of Locally-advanced Rectal Carcinoma After a Favorable Response to Induction Chemotherapy","GRECCAR14","INCLUSION CRITERIA FOR SCREENING\n\n1. Written consent,\n2. Patient who receive Folfirinox,\n3. Patient aged over 18 years old,\n4. World Health Organization (WHO) performance status ≥ 1,\n5. Histologically confirmed diagnosis of adenocarcinoma of the rectum,\n6. Distal part of the tumor from 1 to 12 cm from the upper part of the levator ani (dynamic rectal examination),\n7. No unequivocal evidence on CT-Scan of established metastatic disease,\n8. MRI evaluation of the locally advanced tumor before neoadjuvant chemotherapy:\n\n   1. Predictive CRM \\\u003C 2 mm\n   2. Or T3c-d (extending ≥ 5 mm beyond the muscularis propria) with extra mural venous invasion (EMVI)\n   3. Or T4a-b (except bone and sphincteric invasion).\n\nNON INCLUSION CRITERIA FOR SCREENING\n\n1. Non measurable rectal tumor or not assessed by MRI before inclusion,\n2. Ultra-low rectal tumor at diagnosis which imposes radiotherapy administration (inferior tumor pole less than 1 cm from the upper part of the levator ani).\n3. Active cardiac disease including any of the following: a. Congestive heart failure ≥ New York Heart Association (NYHA) class 2 (appendix 4), b. Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), c. Myocardial infarction less than 6 months before first dose of treatment, d. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted),\n4. Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to study inclusion, except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors \\[Ta (non invasive tumor), Tis (carcinoma in situ) and T1 (lamina propria invasion)\\],\n5. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before start of treatment.\n\nINCLUSION CRITERIA FOR EXPERIMENTAL TREATMENT\n\n1. WHO performance status 0-1,\n2. Patient with tumoral regression ≥ 60% and CRM ≥ 1mm,\n3. No unequivocal evidence on CT-Scan of established metastatic disease,\n4. General condition considered suitable for radical pelvic surgery and a systemic therapy with Capecitabine\n5. Adequate hematologic, hepatic, renal and ionogram function assessed within 7 days prior to study treatment a. Platelet count ≥ 100,000\u002Fmm3; Hemoglobin (Hb) ≥ 9 g\u002FdL; Absolute neutrophil count (ANC) ≥ 1,500\u002F mm3 b. Total bilirubin ≤ 1.5 x Upper Limit Normal (ULN), Alkaline phosphatases ≤ 3 x ULN and ASpartate aminoTransferase (AST) and ALanine aminoTransferase (ALT) ≤ 3 x ULN, c. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml\u002Fmin according to Modification of Diet in Renal Disease (MDRD),\n6. For women of reproductive potential, negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 days before the start of study treatment. Women not of reproductive potential are female patients who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy),\n7. For women of childbearing potential and men, agreement to use an adequate contraception for the duration of study participation and up to 6 months following completion of therapy. Females of childbearing potential who are sexually active with a non-sterilized male partner must use 2 methods, of effective contraception. The investigator or a designated associate is requested to advise the patient on how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care,\n8. No evidence of chronic or acute ischemic heart disease,\n9. Willing to participate to the study, and able to give informed consent and to comply with the treatment and follow-up schedules,\n10. Affiliation to the French Social Security System.\n\nNON-INCLUSION CRITERIA FOR EXPERIMENTAL TREATMENT\n\n1. Patient with a history of pelvic radiotherapy,\n2. Contraindication to chemotherapy and\u002For radiotherapy,\n3. Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng\u002FmL),\n4. Any infection that could jeopardize treatment administration,\n5. Any other serious concomitant disease or disorder that may interfere with the patient's participation in the study and safety during the study (e.g., severe liver, heart, kidney, lung, metabolic, or psychiatric disorders),\n6. History of inflammatory bowel disease,\n7. Patients with a history of pulmonary fibrosis or interstitial pneumonia,\n8. Patients using antivitamin K (Coumadin etc…) but it's possible to substitute the antivitamin K treatment with low molecular weight heparins (LMWHs) before starting chemotherapy,\n9. Known hypersensitivity to Capecitabine drug, study drug classes, or any constituent of the products,\n10. Patient who received live attenuated vaccine within 10 days of inclusion,\n11. Pregnant or breastfeeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (serum β-hCG) documented 72 hours prior to inclusion,\n12. Patient treated with an investigational drug within the last 30 days,\n13. Patient under curatorship or guardianship or safeguard justice,\n14. Inability to submit to medical monitoring of the trial for geographical, social or psychological reasons.","ALL","18 Years",{"count":20,"type":21},1075,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","Locally advanced rectal carcinoma raise the issue of both the oncological control, local and general, and the therapeutic morbidity. Surgery alone can cure only one out of two patients, radiochemotherapy improves the local control but the metastatic risk remains about 30% with enhanced postoperative morbidity and poor functional results. The tumor response to preoperative treatment is the major prognostic factor which revealed the aggressiveness of the tumor. To this day, there are no biologic predictive markers for tumor response.\n\nThe purpose of this trial is to tailor the management according to the early tumoral response after short and intensive induction chemotherapy. MRI volumetric tumor response will be used to distinguish between good responders and bad responders.\n\n\"Very good\" responders will be randomized to either immediate surgery or radiochemotherapy followed by surgery (Standard arm: Cap 50).",[28,29],"Locally Advanced Malignant Neoplasm","Rectal Carcinoma","RECRUITING","2026-02-03",{"date":33,"type":34},"2026-02-05","ACTUAL",{"date":36,"type":34},"2021-11-26",{"date":38,"type":21},"2026-08",{"name":40,"class":41},"Institut du Cancer de Montpellier - Val d'Aurelle","OTHER",30,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100446928","registry-trial-to-evaluate-the-safety-and-efficacy-of-hyperthermia-in-locally-advanced-cancers-100446928","NCT05099809","Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia in Locally Advanced Cancers","Registry Trial to Evaluate the Safety and Efficacy of Hyperthermia with Radiotherapy And\u002For Chemotherapy in Locally Advanced Cancers At MGIMS","RESHMART","Inclusion Criteria:\n\n1. Histopathologically proven cases of locally advanced head and neck cancers (LAHNC), TNM stages III and IV and locally advanced cancer cervix (LACC), FIGO stages IIB - IVA, locally advanced (primarily inoperable T3 and T4 stages) and recurrent breast cancers, cancer oesophagus (TNM stages IIA and IVA), anorectal cancers (TNM stages IIA to IIIC)\n2. Following work up, patients should have no metastatic disease (M0)\n3. Age \\> 18 years\n4. Karnofsky performance status (KPS) ≥ 80\n5. Written informed consent and agree to comply with the protocol\n6. Adequate kidney and liver functions as assessed on biochemical investigations\n7. Absence of psychological, familial, sociological or geographical condition that could potentially hamper compliance with the study protocol and follow-up schedule\n\nExclusion Criteria:\n\n1. Prior radiotherapy to the site of treatment\n2. No prior or concurrent malignancies other than surgically treated squamous cell or basal cell carcinoma of the skin which are not in the area of the present malignancy\n3. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator would preclude the patient from meeting the study requirements.\n4. Patients having metal implants, pacemakers or clustered markers.\n5. Connective disease disorders that contraindicate radiotherapy, e.g., Scleroderma\n6. Any known contraindication or hypersensitivity to the chemotherapeutic agents\n7. Pregnancy, lactation period or lack of reliable contraception\n8. Any other disease or therapy, which, according to the investigator, present a risk to the patient or which are not compatible with the aims of the clinical trial\n9. Indications that the person concerned will possibly not keep to the clinical trial plan because of unwillingness to cooperate or difficulties in keeping the check-up appointments\n10. Breast feeding female patients",{"count":52,"type":21},500,"OBSERVATIONAL","Mahatma Gandhi Institute of Medical Sciences (MGIMS), Sevagram, District Wardha, Maharashtra, India is located in a rural setup and caters to a very underprivileged patient population with limited resources to even pay for their treatment. As per the latest Indian Cancer Registry Report 2020, of the 28 population based cancer registries (PBCR), the age adjusted incidence rates (AAR) in males and females are 64.9 and 69.9. This makes the AAR in Wardha District (district where MGIMS is located) as one of the lowest ranked AAR both for male (national range: 39.5 - 269.4) and females (national range: 49.4 - 219.8) in the country. However, the %mortality \u002F incidence, is one of the highest for Wardha, both for males (65.9%, national range: 14.7% - 71.9%) and females (53%, national range: 9% - 63%). This indicates that the prognosis of patients in this district is one of the worst in India and thus requires a new approach to their standard therapeutic option. This has to be cost-effective, without any significant additional morbidity, and should used in conjunction to the standard treatment of radiotherapy and\u002For chemotherapy.\n\nHyperthermia, which is raising the tumor temperature to 40 - 43°C is perhaps one of the oldest forms of treatment for cancer. Hyperthermia, being a potent radiosensitizer, a chemosensitizer, an immunomodulator with no significantly added side effects, could be an effective therapeutic modality that could be expected to improve the outcome in these patients. However, it also needs to be cost-effective and require low capital cost investment so that other centers, especially in low and low-middle income countries could also introduce hyperthermia to the therapeutic armamentarium for cancer.\n\nThis is a registry trial for patients being treated with hyperthermia along with radiotherapy and\u002For chemotherapy as per the standard departmental protocol for various locally advanced cancers.",[28],[57,58,59,60,61],"Hyperthermia","Radiotherapy","Chemotherapy","Registry trial","Short wave diathermy","2024-09-09",{"date":64,"type":34},"2024-09-19",{"date":66,"type":34},"2021-10-18",{"date":68,"type":21},"2025-09-30",{"name":70,"class":41},"Mahatma Gandhi Institute of Medical Sciences",1]