2024-512726-28-00招募中4 期
Multicentre Phase IV clinical trial to evaluate the efficacy of hyperthermic intraoperative chemotherapy (HIPEC) with Mitomycin-C after complete surgical debulking in patients with peritoneal metastases of colon cancer.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 216
- 试验地点
- 30
- 主要终点
- peritoneal recurrence-free survival at 1, 2 and 3 years.
研究概览
简要总结
To evaluate whether there are differences in PERITONEAL RECURRENCE in patients with Colon Cancer Peritoneal Metastases treated with complete surgical resection and QTS, with (Group 1) or without (Group 2) HIPEC with Mitomycin-C.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven colon cancer, except those with signet ring cells (those with > 50% of the tumor composed of such cells, which only account for 1% of CRC).
- •Absence of current or previously treated extraperitoneal metastases, including distant adenopathies (retroperitoneal, mediastinal,...), liver metastases, or pulmonary metastases (ruled out by PET in case of doubt).
- •Synchronous or metachronous peritoneal carcinomatosis of mild or moderate extension, with a PCI ≤ 20 (APPENDIX I) (intraoperative evaluation).
- •Obtaining a macroscopically complete surgical cytoreduction CCS-0 (intraoperative evaluation).
- •Treatment with perioperative systemic chemotherapy (before and/or after the surgical procedure).
- •Age > 18 years.
- •Acceptable anesthetic/surgical risk: ASA 1-3 (APPENDIX II), ECOG 0-1 (APPENDIX III), hematological, renal and hepatic function without severe alterations (operable patients).
- •Information to the patient and signature of the study-specific Informed Consent.
排除标准
- •Peritoneal carcinomatosis of any other origin, in particular rectal cancer or appendiceal adenocarcinoma, or signet ring cell colon cancer on histology.
- •Urgent intervention for obstruction or perforation of a primary tumor with synchronous MP (although salvage or secondary CR + HIPEC after emergency surgery of the primary tumor are acceptable if the inclusion criteria are met).
- •Persons deprived of liberty or under guardianship.
- •Inability to understand the nature of the intervention, the risks, benefits, expected evolution and need to undergo periodic medical examinations, either for geographical, social or psychological reasons.
- •No intraoperative confirmation of peritoneal disease (PCI 0). Cases of perianastomotic (local) or lymph node (locoregional) recurrence will also be excluded.
- •High volume peritoneal carcinomatosis, with a PCI > 20 (APPENDIX I), or incomplete cytoreduction (intraoperative evaluation).
- •Concurrent or previously treated extraperitoneal disease.
- •Progression during preoperative chemotherapy, if received.
- •Patients previously treated with HIPEC.
- •History of other cancers (except cutaneous basal cell carcinoma or carcinoma in situ of the cervix) in the 5 years prior to study entry.
- •Patient included in another first-line clinical trial for the disease studied.
- •Pregnancy (or suspected pregnancy) or lactation period.
结局指标
主要结局
peritoneal recurrence-free survival at 1, 2 and 3 years.
peritoneal recurrence-free survival at 1, 2 and 3 years.
次要结局
- Overall recurrence (ORS) at 1, 2 and 3 years.
- Locoregional and distant recurrence (isolated or coincident, with or without simultaneous peritoneal recurrence) at 1, 2, and 3 years.
- Postoperative complications using the CTCAE v5.0 90-day adverse event classification system, including those related to HIPEC.
- Prognostic factors for peritoneal and global recurrence: synchronous/metachronous PM, perioperative QTS, use of biological agents or immunotherapy, stratified PCI (1-10, 11-15, 16-20), postoperative complications, right/left colon, degree of differentiation, vascular/lymphatic/perineural invasion, RAS/RAF status, microsatellite instability and degree of peritoneal tumour regression.
- Overall survival at 1, 2 and 3 years.
- Study of Quality of Life in both groups using the EORTC QLQ-C30 and QLQ-CR29 questionnaires (APPENDIX IV), to be carried out at the aforementioned times.
- Correlation surgical PCI - pathological PCI
研究者
Fernando Pereira
Scientific
Hospital Universitario De Fuenlabrada
研究点 (30)
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