[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iii-fallopian-tube-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iii-fallopian-tube-cancer":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,60,102],{"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":40,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100472291","a-study-comparing-perioperative-stress-reduction-vs-standard-of-care-in-ovarian-cancer-preserve-100472291",false,"NCT05429970","A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)","Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study","Inclusion Criteria:\n\n* Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment\n* Scheduled to undergo exploratory laparotomy and PDS or IDS\n* Scheduled for surgery with at least 10 days of lead time, to allow the participant to take the β-blocker and COX2 inhibitor 7 days preoperatively\n* Age ≥18 years\n* ASA score of 1 to 3\n* Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent\n\nExclusion Criteria:\n\n* Chronic treatment with any β-blocker or COX inhibitor\n* Contraindication for β-blocker therapy (asthma, second- or third-degree atrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease)\n* Contraindication for COX2 inhibitor therapy (renal failure \\[creatinine level \\>1.5 mg\u002FdL\\], significant liver failure \\[known cirrhosis, bilirubin level \\>2\\], active peptic disease), or current use of oral anticoagulant)\n* Contraindication for regional epidural anesthesia\n* Chronic autoimmune disease\n* Active infection\n* Pregnant\n* Minimally invasive procedure\n* Participation in another clinical trial that interferes with this study","FEMALE","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training\u002FMBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery\u002FPDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Ovarian Cancer","Ovarian Carcinoma","Stage II Ovary Cancer","Stage II Ovarian Cancer","Stage III Ovary Cancer","Stage III Ovarian Cancer","Stage IV Ovary Cancer","Stage IV Ovarian Cancer","Epithelial Ovarian Cancer","Fallopian Tube Cancer","Stage II Fallopian Tube Cancer","Stage III Fallopian Tube Cancer","Stage IV Fallopian Tube Cancer","Primary Peritoneal Carcinoma",[41,42,43,44,45,46,34,35,39],"ovarian cancer","propranolol","etodolac","MBRT","mind-body resilience training","music therapy","RECRUITING","2026-06-30",{"date":50,"type":51},"2026-07-01","ACTUAL",{"date":53,"type":51},"2022-06-17",{"date":55,"type":20},"2027-06-17",{"name":57,"class":58},"Memorial Sloan Kettering Cancer Center","OTHER",7,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100424807","phase-1-pressurized-intraperitoneal-aerosol-chemotherapy-pipac-associated-with-systemic-chemotherapy-in-women-with-advanced-ovarian-cancer-100424807","NCT04811703","Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer","Phase I Dose Escalation Study Evaluating the Safety of Adding Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin-doxorubicin to the Systemic Chemotherapy, and the Recommended Phase II Dose, in Women With Insufficient Response to Carboplatin-paclitaxel for Advanced Epithelial Cancer of the Ovary, Fallopian Tubes or Peritoneum","PIPACOVA","Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 75 years;\n* ECOG Performance Status 0-2;\n* Histologically confirmed epithelial carcinoma of the ovary, fallopian tubes, or peritoneum, FIGO stage IIb to IVa, with a tumor response after three cycles of carboplatin-paclitaxel that does not correspond to disease progression but is insufficient to allow complete cytoreductive surgery, as assessed by the investigators after multidisciplinary tumor board discussion and validation;\n* Adequate hematological function:\n\n  * Absolute neutrophil count \\> 1,500\u002Fmm³ (or 1.5 × 10⁹\u002FL);\n  * Hemoglobin ≥ 9.0 g\u002FdL;\n  * Platelet count \\> 100 × 10⁹\u002FL;\n* Adequate renal and hepatic function:\n\n  * Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or estimated glomerular filtration rate ≥ 60 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation);\n  * Total bilirubin ≤ 1.5 × ULN;\n  * AST and ALT ≤ 1.5 × ULN (≤ 5 × ULN in patients with liver metastases);\n* No unstable medical conditions, including myocardial infarction within 6 months prior to study entry, congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer disease, or any condition that could be worsened by the study treatment or impair compliance, as judged by the investigator;\n* Written informed consent obtained prior to any study-specific procedures;\n* Patient affiliated with a national health insurance system.\n\nExclusion Criteria:\n\n* Extra-peritoneal metastases whose location or extent precludes a potentially curative surgical procedure;\n* Signs of bowel obstruction, bowel lesions with a high risk of intestinal perforation based on their location, or evidence of inflammatory bowel disease;\n* Contraindication to intravenous carboplatin-paclitaxel chemotherapy, including known severe hypersensitivity to paclitaxel;\n* Contraindication to PIPAC procedures, including:\n\n  * Known hypersensitivity to cisplatin or other platinum compounds;\n  * Known hypersensitivity to doxorubicin or other anthracyclines or anthracenediones;\n  * Cardiac disease with myocardial insufficiency;\n  * Uncontrolled coronary artery disease;\n* Known hypersensitivity to sodium thiosulfate, sulfites, or any of its excipients;\n* Administration of a live attenuated vaccine within 3 months prior to study treatment initiation or planned during the study;\n* Pregnant or breastfeeding women;\n* Individuals deprived of liberty, under guardianship, or subject to legal protection measures;\n* Participation in another interventional research study with an ongoing exclusion period at inclusion, or in a study that could interfere with the results of the present study, as judged by the investigator;\n* Inability to comply with study follow-up for geographical, social, or psychological reasons, as judged by the investigator.","75 Years",{"count":70,"type":20},15,[72],"PHASE1","Women with a history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of prior neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively enrolled in this phase I study. After providing written informed consent and confirmation of unresectable disease by multidisciplinary assessment, patients will undergo three cycles of combined chemotherapy consisting of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with doxorubicin and cisplatin at escalating dose levels, combined with systemic intravenous chemotherapy using carboplatin and paclitaxel at standard doses. Treatment cycles will last 28 days, with PIPAC administered on Day 1 and systemic chemotherapy on Day 8, for a maximum of three cycles in the absence of unacceptable toxicity.\n\nDose escalation of PIPAC chemotherapy will follow a Continual Reassessment Method (CRM) algorithm. The first patient will be treated at the lowest dose level, and subsequent patients will receive the recommended dose according to the CRM, conditional on the occurrence of dose-limiting toxicity (DLT) observed during Cycle 1. From dose level 7 onward, corresponding to cisplatin and doxorubicin doses associated with an increased risk of renal toxicity, sodium thiosulfate will be systematically administered prior to each PIPAC procedure for its nephroprotective effect, in accordance with the cisplatin dose level and current clinical practice.\n\nThe primary objective of the study is to determine the maximum tolerated dose (MTD) of doxorubicin-cisplatin administered by PIPAC and to define the recommended dose for a subsequent phase II trial. DLTs will be actively collected and reviewed as soon as they are identified during the first treatment cycle.\n\nSecondary objectives include evaluation of pathological response, radiological tumor response, and changes in the extent of peritoneal disease following combined chemotherapy, as well as characterization of the pharmacokinetics of PIPAC-administered drugs. Additional exploratory objectives include assessment of the KELIM parameter as a predictive marker of sensitivity to combined chemotherapy and evaluation of the overall safety profile of the treatment strategy.\n\nOn Day 1 of the first treatment cycle, blood samples will be collected for pharmacokinetic analysis of doxorubicin and cisplatin. Serum CA-125 levels will be measured before each intraperitoneal or intravenous chemotherapy administration throughout the study. At the end of combined chemotherapy, radiological tumor assessment by CT scan or MRI and a final CA-125 measurement will be performed. Patients achieving complete response, partial response, or stable disease according to RECIST v1.1 criteria will undergo re-evaluation for surgical resectability. If complete cytoreductive surgery is deemed feasible, surgery will be scheduled with a post-operative follow-up visit planned one month later. Patients with progressive or persistently unresectable disease will discontinue study participation.",[75,76,31,33,37,38,77],"Metastatic Ovarian Carcinoma","Peritoneal Carcinomatosis","Metastatic Malignant Neoplasm in the Peritoneum",[79,80,81,82,83,84,85,86,87,88,89,90,91],"Dose escalation","Phase I study","Intravenous Chemotherapy","Intraperitoneal chemotherapy","PIPAC","RP2D","cytoreductive surgery","Ovarian epithelial cancer","peritoneal cancer","doxorubicin","cisplatin","CA-125 antigen","pharmacokinetic","2026-05-18",{"date":94,"type":51},"2026-05-22",{"date":96,"type":51},"2021-07-30",{"date":98,"type":20},"2029-01",{"name":100,"class":58},"Hospices Civils de Lyon",6,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":130},"100489919","phase-3-heated-intraperitoneal-chemotherapy-followed-by-niraparib-for-ovarian-primary-peritoneal-and-fallopian-tube-cancer-100489919","NCT05659381","Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer","GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Homologous Recombinant Deficient (HRD +) Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)","HOTT","Inclusion Criteria:\n\n1. Patients must have a pathologic diagnosis of high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, FIGO stage III or IV documented on CT scan\u002FMRI, must be recommended and agree to undergo platinum-based neoadjuvant chemotherapy with or without physician choice bevacizumab (3-4 cycles allowed, with bevacizumab held for at least 28 days preoperatively) and are considered candidates for (and planned to have) interval cytoreductive surgery (iCRS) followed by chemotherapy and niraparib maintenance as determined by the enrolling investigator. Patients may continue bevacizumab after a minimum of 28 days post iCRS and during niraparib maintenance per local standard.\n2. Patients with stage IV disease must have complete response of extra-abdominal disease on preoperative imaging (e.g. pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases) or be deemed resectable with iCRS.\n3. Patients must have HRD\u002FLOH positive tumors. Patients with germline or somatic BRCA or other similar mutations (RAD51C, RAD51D, BRIP1, BARD) are not required to have HRD\u002FLOH testing. Patients without BRCA or germline mutations must have HRD\u002FLOH testing using Myriad myChoice®\u002FFoundation Medicine\u002FCaris Life Sciences platforms. HRD test results must be available prior to registration to meet entry criteria.\n4. Patients must have R0 (no gross\u002Fvisible residual disease) or R1 (gross\u002Fvisible residual disease ≤ 1.0 cm in the longest diameter) following iCRS and prior to randomization.\n5. Patient must have adequate bone marrow and organ function:\n\n   Bone marrow function:\n\n   Hemoglobin ≥ 8.5 g\u002FdL. Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm3. Platelets ≥ 100,000\u002Fmm3.\n\n   Renal function:\n\n   Creatinine ≤ 1.3mg\u002Fdl OR Calculated creatinine clearance (≥ 30 mL\u002Fmin\u002F1.73 m2) per National Kidney Foundation guidelines and NHANES III\n\n   Hepatic function:\n\n   Bilirubin ≤ 1.5 times ULN. ALT ≤ 3 times the ULN. AST ≤ 3 times the ULN.\n\n   Neurologic function:\n\n   Peripheral neuropathy ≤ CTC AE grade 2.\n6. Patients must have an ECOG performance status of 0 or 1.\n7. Patient must be age \\> 18.\n8. Patients must have a life expectancy \\> 3 months.\n9. Patients of childbearing potential must have a negative serum pregnancy test within 28 days prior to iCRS and must be practicing an effective form of contraception (with failure rate \\\u003C1% per year) during the study period and for 6 months following the last dose of niraparib. Patients of childbearing potential must consent to pregnancy testing prior to receiving niraparib and monthly thereafter for the duration of the study.\n\n   Patients are considered postmenopausal and not of child-bearing potential if they are free from menses for \\>1 year or surgically sterilized.\n10. Patients must have normal blood pressure (BP) or adequately treated and controlled hypertension based on local standard of care (systolic BP ≤ 140 mmHg and diastolic ≤ 90 mmHg) prior to starting niraparib.\n11. Patients receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to randomization.\n12. Patients must agree to not donate blood during the study or for 90 days after the last dose of study treatment.\n13. Patients with known human immunodeficiency virus (HIV) are allowed if they meet all the following criteria:\n\n    1. Cluster of differentiation 4 ≥350\u002FµL and viral load \\\u003C400 copies\u002FmL\n    2. No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to enrollment\n    3. No history of HIV associated malignancy for the past 5 years\n    4. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started \\>4 weeks prior to study enrollment\n14. Patient or a legally authorized representative must have signed an approved informed consent and authorization permitting the release of personal health information.\n\nExclusion Criteria\n\n1. Patients with low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers and borderline tumors.\n2. Patients who have received prior treatment for ovarian cancer other than the first 3-4 cycles of platinum based neoadjuvant chemotherapy. Prior neoadjuvant treatment with bevacizumab is allowed; bevacizumab must be held for 28 days prior to surgery.\n3. Patients whose tumors are HRD\u002FLOH negative.\n4. Patients not eligible for iCRS based on evidence of progression of disease during neoadjuvant chemotherapy (documented on CT scan\u002FMRI required within 35 days of iCRS).\n5. Patients not eligible for iCRS based on medical co-morbidities as per the enrolling investigator.\n6. Patients with stage IV disease without complete response of extra-abdominal disease on preoperative findings (e.g., pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, mesemchymal liver metastases or other extra-abdominal metastases) who are not deemed resectable with iCRS.\n7. Patients with a history of Myelodysplastic Syndrome or Acute Myeloid Leukemia.\n8. Patients who are pregnant or lactating.\n9. Patients with a severe infection requiring IV antibiotics within 2 weeks of planned randomization.\n10. Patients with other uncontrolled, intercurrent medical conditions.\n11. Patient with metastatic disease to the central nervous system.\n12. Patient with uncontrolled insulin dependent diabetes or pre-existing renal condition.\n13. Patients with pre-existing hearing loss related to prior platinum-based chemotherapy.\n14. Patients with Prior Reversible Encephalopathy Syndrome (PRES).\n15. Patients with current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment). Severe hepatic impairment patients should be excluded.\n16. Patients with any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and\u002For bowels that is not related to ovarian cancer.\n17. Patients with clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina \\\u003C6 months to randomization, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident within 6 months).\n18. Patients with an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to study randomization and\u002For history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).\n19. Patients with known active hepatitis B (eg, hepatitis B surface antigen reactive) are excluded unless their HBV is stably controlled on nucleos(t)ide analogs (eg entecavir or tenofovir) which will be continued for the duration of the study.\n20. Patient has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to study randomization.\n21. Patient has received a live vaccine within 30 days of study randomization. COVID-19 vaccines that do not contain live viruses are allowed at any time during the study.\n22. Patient has a diagnosis, detection, or treatment of another type of invasive cancer ≤ 2 years prior to initiating protocol therapy (except for basal or squamous cell carcinoma of the skin, cervical cancer in situ, and ductal cancer in situ (DCIS) that has been definitively treated).\n23. Patients must not have had radiotherapy encompassing \\> 20% of the bone marrow within 2 weeks of randomization; or any radiation therapy within 1 week prior to randomization.",{"count":111,"type":20},220,[113],"PHASE3","Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +\u002F- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.\n\nFollowing completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \\>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg\u002Fm2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery.\n\nBoth groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +\u002F- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +\u002F- bevacizumab until progression or 36 months (if no evidence of disease).",[31,33,116,117,37,38],"Stage III Primary Peritoneal Cancer","Stage IV Primary Peritoneal Cancer",[119],"HIPEC","2026-04-15",{"date":122,"type":51},"2026-04-16",{"date":124,"type":51},"2024-03-08",{"date":126,"type":20},"2034-08-01",{"name":128,"class":129},"GOG Foundation","NETWORK",59]