Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer
| العنوان: | Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer |
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| المؤلفون: | Koole, S., Stein, R., Sikorska, K., Barton, D., Perrin, L., Brennan, D., Zivanovic, O., Mosgaard, B.J., Fagotti, A., Colombo, P.E., Ham, M.A. van, Ottevanger, P.B., Sonke, G., Driel, W.J. van |
| المساهمون: | Interne Geneeskunde, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: MA Medische Oncologie (9), Epidemiology |
| المصدر: | International Journal of Gynecological Cancer, 30(6), 888-892. BMJ Publishing Group Int J Gynecol Cancer International Journal of Gynecological Cancer, 30, 888-892 International Journal of Gynecological Cancer, 30, 6, pp. 888-892 |
| بيانات النشر: | BMJ Publishing Group, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | operative, medicine.medical_specialty, Bevacizumab, medicine.medical_treatment, Hyperthermic Intraperitoneal Chemotherapy, Carcinoma, Ovarian Epithelial, Article, law.invention, 03 medical and health sciences, surgical oncology, CISPLATIN, 0302 clinical medicine, Randomized controlled trial, SDG 3 - Good Health and Well-being, law, Surgical oncology, peritoneal neoplasms, medicine, Clinical endpoint, Fallopian Tube Neoplasms, Humans, 030212 general & internal medicine, Stage (cooking), Randomized Controlled Trials as Topic, Ovarian Neoplasms, Chemotherapy, business.industry, Obstetrics and Gynecology, LONG-TERM SURVIVAL, Cytoreduction Surgical Procedures, medicine.disease, Women's cancers Radboud Institute for Health Sciences [Radboudumc 17], Surgery, surgical procedures, Settore MED/40 - GINECOLOGIA E OSTETRICIA, ovarian cancer, Oncology, Clinical Trials, Phase III as Topic, 030220 oncology & carcinogenesis, Hyperthermic intraperitoneal chemotherapy, Female, business, Ovarian cancer, medicine.drug |
| الوصف: | BackgroundThe addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.Primary objectiveThe primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.Study hypothesisWe hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.Trial designThis international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.Major eligibility criteriaPatients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.Primary endpointThe primary endpoint is overall survival.Sample sizeTo detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.Estimated dates for completing accrual and presenting resultsThe OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.Trial registrationClinicalTrials.gov:NCT03772028 |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1048-891X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b94a2946b1f4d3dcfb7946e09169545d https://doi.org/10.1136/ijgc-2020-001231 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....b94a2946b1f4d3dcfb7946e09169545d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1048891X |
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