Prophylactic PIPAC in Patients With High-risk Colorectal Cancer

Официальное название

Prophylactic PIPAC for Reducing the Risk of Peritoneal Carcinomatosis in Patients With Colorectal Cancer: the PROPAC Randomized Clinical Trial

Обзор

In a multicentric randomized controlled trial, we will compare standard surgery (consisting in removal of the primary cancer) followed by 6 months of adjuvant chemotherapy associated with 3 cycles of oxaliplatin-based PIPAC (4-6 weeks apart), to standard surgery followed by 6 months of adjuvant systemic chemotherapy (routine treatment), in patients with colorectal cancer at high risk for metachronous peritoneal carcinomatosis (pT4 pN0-2 cM0 pMMR colorectal cancer of the colon, colorectal junction or high rectum and/or with positive cytology) in terms of 1-year and 3-year peritoneal metastasis-free survival (as measured by imaging and/or surgical exploration), 1-year and 3-year disease-free survival, as well as 1-year and 3-year overall survival. In terms of outcomes measurement, patients in both groups will benefit from diagnostic laparoscopy at 6 months from the index surgery, and standard surveillance consisting in clinical examination, CEA determination and thoraco-abdominal CT at 6, 12, 24, 36, 48 and 60 months after index surgery.

Вмешательства

• Процедура oxaliplatin-based PIPAC
  Patients operated for pT4 pN0-2 cM0 pMMR colorectal cancer (of the colon, colorectal junction or high rectum) or patients operated for pT3-4 pN0-2 cM0 pMMR colorectal cancer with positive cytology or in patients with pT3-4 pN0-2 M1c pMMR colorectal cancer with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion, will undergo 6 months of adjuvant systemic chemotherapy associated with 3 cycles of oxaliplatin
• Процедура Control (Standard treatment)
  Patients operated for pT4 pN0-2 cM0 pMMR colorectal cancer (of the colon, colorectal junction or high rectum) or patients operated for pT3-4 pN0-2 cM0 pMMR colorectal cancer with positive cytology or in patients with pT3-4 pN0-2 M1c pMMR colorectal cancer with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion, will undergo 6 months of adjuvant systemic chemotherapy, followed by exploration laparoscopy (i

Первичные конечные точки

• 1-year peritoneal metastasis-free survival, [Срок оценки: 1-year]

Вторичные конечные точки (5)

• 3-year peritoneal metastasis-free survival [Срок оценки: 3-year]
• Disease-free survival (DFS) [Срок оценки: 1-year, 3-years]
• Overall survival (OS) [Срок оценки: 1-year, 3-year]
• 30-day incidence of complications [Срок оценки: 30-day]
• EORTC QLQ-C30 score 29 [Срок оценки: 1 month, 2 months, 4 months, 6 months, 12 months, 24 months and 36 months]

Критерии участия

Критерии включения

• Patients operated (in emergency or elective settings) for colorectal cancer (of the colon, colorectal junction or high rectum).
• Definitive pathological stage pT4 pN0-2 cM0 pMMR and/or pT3-4 pN0-2 cM0 pMMR with positive cytology and/or pT3-4 pN0-2 M1c pMMR with limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion (small indeterminate pulmonary nodules to be followed are accepted)
• Performance status 0-1.
• Age > 18 years.
• Written informed consent.

Критерии исключения

• Infraperitoneal rectal cancer (middle or low rectum).
• Age <18 year old.
• Age > 80 year old.
• Hereditary colorectal cancer.
• dMMR/MSI colorectal cancer.
• Inflammatory bowel disease.
• Distant metastasis (outside limited peritoneal carcinomatosis which is limited to one abdominal quadrant and was resected during index surgery and no other distant lesion; small indeterminate pulmonary nodules to be followed are accepted)
• Neo-adjuvant treatment.
• Pregnancy or lactation.
• Immunosuppression.
• Unable to provide informed consent.
• Previous cytoreductive surgery (CRS) (outside limited resection of peritoneal carcinomatosis during index surgery).
• Contraindication to laparoscopy (e.g. severe adhesions, peritonitis).
• Contraindication to and/or no adjuvant chemotherapy.
• History of allergic reaction to oxaliplatin or other platinum-containing compounds.
• Renal impairment, defined as GFR < 50 ml/min, (Cockcroft-Gault equation).
• Myocardial insufficiency, defined as NYHA class > 2.
• Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
• Inadequate hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06839092 · PROPAC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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