CHIPPI-1808: Phase III randomized clinical trial evaluating hyperthermic intraperitoneal chemotherapy (HIPEC) in ovarian cancer considering two different settings: Primary Debulking Surgery (PDS) and Interval Debulking Surgery (IDS)

Centre Oscar Lambret16 个研究点分布在 2 个国家目标入组 352 人2024年11月18日

概览

阶段: 3 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Centre Oscar Lambret
入组人数: 352
试验地点: 16
主要终点: Disease-Free Survival (DFS) will be computed as the time interval between randomization and progression, relapse or death from any cause. Progression and relapses will be assessed according to GCIG criteria1 and ideally confirmed by local tumor board. For patients alive without progression or relapse, data will be censored at the date of last follow-up visit.
状态: 招募中
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The primary objective of this trial is to assess the efficacy, in terms of disease-free survival (DFS), the use of HIPEC treatment combined with standard care (PDS or IDS) or standard care alone (PDS or IDS alone).

注册库

euclinicaltrials.eu

开始日期

2024年11月18日

结束日期

待定

最后更新

去年

性别

Female

研究者

发起方

Centre Oscar Lambret

责任方

Principal Investigator

主要研究者

Clinical Research Sponsor Unit

Scientific

Centre Oscar Lambret

入排标准

入选标准

•Age ≥18 years and ≤ 76 years
•Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up
•Signed, IRB-approved written informed consent
•Patient covered by the French or Belgian “Social Security” regime
•Criteria to be checked per-operatively for confirmation of enrolment and randomization : Residual disease after surgery CC-0 (no macroscopic residue) or CC-1 (residue < 2.5 mm)
•Criteria to be checked per-operatively for confirmation of enrolment and randomization : Per-operative hemorrhage < 2.5 L
•Criteria to be checked per-operatively for confirmation of enrolment and randomization : Strictly less than 3 digestive resections (other than appendectomy) performed during surgery
•Criteria to be checked per-operatively for confirmation of enrolment and randomization : Diuresis maintained during surgery, without oliguria or anuria (per-operatory diuresis ≥ 0,5 mL/ kg/ h)
•Histologically proven primary epithelial ovarian carcinoma or fallopian tube carcinoma or peritoneal carcinoma (serous papillary adenocarcinoma, clear-cell carcinoma, mucinous adenocarcinoma and endometrioid carcinoma). In case of Primary Debulking Surgery (PDS), the patient can be included based on an extemporaneous diagnosis of stage III invasive carcinoma.
•Pre-therapeutic FIGO stage III

排除标准

•Benign disease, borderline disease, non epithelial ovarian carcinoma or carcinosarcoma
•Pregnant or breastfeeding woman
•Psychiatric illness or social situation that would limit compliance with study requirement, substantially increase the risk of side effects, or compromise the ability of the patient to give written informed consent
•Inability to comply with medical follow-up of the trial (geographical, social or psychic reasons)
•Person under guardianship or curatorship
•Known hypersensitivity to any of the trial drugs, trial drug classes, or excipients in the formulation
•Auditory impairment (i.e. if hearing aid is fitted or if the patient is complaining. In cases of doubt, an audiogram should be performed.)
•Dehydration or intercurrent disease that contraindicates hyperhydration (including cardio-respiratory disease)
•Other uncontrolled intercurrent disease including, but not limited to: diabetes; hypertension; symptomatic congestive heart or pulmonary failure; renal, hepatic or severe gastrointestinal (associated with diarrhea) chronic disease
•Any unresolved NCI-CTCAE Grade ≥ 2 toxicity from previous anticancer therapy (excluding alopecia), or NCI-CTCAE Grade ≥ 3 for anemia

结局指标

主要结局

Disease-Free Survival (DFS) will be computed as the time interval between randomization and progression, relapse or death from any cause. Progression and relapses will be assessed according to GCIG criteria1 and ideally confirmed by local tumor board. For patients alive without progression or relapse, data will be censored at the date of last follow-up visit.

次要结局

Overall survival : OS will be computed as the time interval between randomization and death from any cause. For patients alive, data will be censored at the date of last follow-up.
Adverse events will be evaluated according to NCI-CTCAE V5.0 over the whole treatment duration from randomization up to the end of treatment (surgery or chemotherapy) plus 30 days, excluding AE unequivocally related to the disease under study or its progression. Adverse events of grade 3 or more (grade 3+) will be counted as severe adverse events.
The impact of HIPEC on the feasibility of adjuvant treatment will be assessed by describing the time interval between surgery and start of adjuvant chemotherapy. We will consider that start of chemotherapy is delayed if this time interval is larger than 6 weeks. In this case, the reasons will be described. - describing the total number of chemotherapy courses (neo-adjuvant+adjuvant). If the total number of chemotherapy course is below the planned number of 6, the reasons will be described.
Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) computed from survival times (overall survival and progression-free survival) and adverse events data (date of occurrence of grade 3+ adverse event) as detailed in the statistical considerations.
Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Score 30 (QLQ-C30), and Quality of Life Questionnaire–Ovarian Cancer Module (QLQ-OV28)
Exploratory endpoint : Count of residual viable cells (evaluated by flow cytometry) in abdominal drainage fluids
Exploratory endpoint : Further research projects on the constituted biobank (tumor samples and blood samples) could be performed if additional and specific funding is obtained