2024-514706-31-01招募中3 期
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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 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.
研究概览
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).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
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
- •Patient eligible for a. Primary Debulking Surgery (PDS) with planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy b. Or Interval Debulking Surgery (IDS) after neo-adjuvant chemotherapy +/- bevacizumab or other targeted therapy, with or without planned adjuvant chemotherapy +/- bevacizumab or other targeted therapy. In case of neo-adjuvant chemotherapy, surgery should be performed in a time interval of 3 to 5 weeks in case of chemotherapy without bevacizumab, and in a time interval of 4 to 6 weeks if chemotherapy is combined with bevacizumab. The patient remains eligible for the trial if surgery is delayed beyond the recommended time interval.
- •WHO Performance Status ≤ 2
- •Physical status score ASA2 ≤ 2 or ASA = 3 if only related to a BMI ≥ 40 or to malignant ascites
- •Adequate bone marrow and renal function, as evidenced by the following tests performed within 7 days prior to surgery: - Absolute Neutrophil Count (ANC) ≥1,500/mm3 - Platelets ≥100,000/mm3 - Aspartate aminotransferase (ALT)/ Alanine aminotransferase (ALT) ≤2.5 × upper normal limit (UNL) (≤5.0 × ULN in case of liver metastases) - Total bilirubin ≤1.5 × ULN (except in case of Gilbert’s disease) - Creatinine clearance ≥ 60 mL/ min/ 1.73m2 (estimated according to MDRD formula)
- •Negative serum pregnancy test within 7 days prior to surgery for women of childbearing potential. For non-menopaused women, if no hysterectomy is planned, willing to accept the use of an effective contraceptive regimen3 during the treatment period and at least 6 months after the end of treatment (surgery or adjuvant chemotherapy)
- •Absence of contraindication to receive the products used in this study (cisplatin and products used in neo-adjuvant/ adjuvant chemotherapy) according to the most recent SmPC of these products (available at http://base-donnees-publique.medicaments.gouv.fr/)
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
- •Concomitant treatment with prophylactic phenytoin
- •Receipt of live attenuated vaccine, including yellow fever vaccine, within 30 days prior to inclusion (and, if patient is enrolled, up to 30 days after the last administration of study treatment)
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.
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
研究者
Clinical Research Sponsor Unit
Scientific
Centre Oscar Lambret
研究点 (16)
Loading locations...
相似试验
招募中
3 期
Extension Study for Participants in Studies That Include Pembrolizumab2022-501254-10-00Merck Sharp & Dohme LLC1,133
招募中
1 期
A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.NCT07258979MediLink Therapeutics (Suzhou) Co., Ltd.202
招募中
2 期
An Open Label Study of JNJ-68284528, Directed Against BCMA in Subjects with Multiple MyelomaMultiple Myeloma2023-506587-13-00Janssen - Cilag International56
招募中
不适用
Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell LymphomaNCT07257510Peking University Third Hospital34
未知
3 期
Phase III Clinical Trial, long term treatment with TO-204 - Subcutaneous immunotherapy in patients with HDM-sensitized allergic rhinitis and asthma -jRCT2080221855TORII PHARMACEUTICAL CO., LTD.30