Clinical trial · Interventional
Preoperative Systemic Therapy for Colorectal Cancer Peritoneal Metastases
Preoperative Systemic Therapy With FOLFOXIRI Plus Bevacizumab Followed by Cytoreductive Surgery Versus Upfront Cytoreductive Surgery for Resectable Colorectal Peritoneal Metastases: A Randomized Phase 2 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, parallel-group, phase 2 randomized trial which randomizes patients with isolated resectable colorectal cancer peritoneal metastases to receive preoperative systematic therapy followed by CRS+HIPEC and postoperative chemotherapy or upfront CRS+HIPEC followed by postoperative chemotherapy.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cytoreductive Surgery | — | UNRESOLVED | — |
| Hyperthermic Intraperitoneal Chemotherapy | — | UNRESOLVED | — |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
| Peritoneal Metastases | — | UNRESOLVED | — |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CRS+HIPEC | Procedure | — | UNRESOLVED |
| Postoperative chemotherapy | Drug | — | UNRESOLVED |
| Preoperative systematic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Chemotherapy group
- description
- 6 cycles of mFOLFOXIRI±Bev is followed by cytoreductive surgery. Postoperative 6 cycles of mFOLFOX is scheduled.
- interventionNames
- Drug: Preoperative systematic therapy
- Procedure: CRS+HIPEC
- Drug: Postoperative chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Upfront surgery group
- description
- Upfront surgery group is followed by 12 cycles of mFOLFOX+Bev
- interventionNames
- Procedure: CRS+HIPEC
- Drug: Postoperative chemotherapy
Primary outcomes (1)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Historically and radiologically confirmed colorectal cancer peritoneal metastasis except for appendical origin; * Tolerable to scheduled chemotherapy; * No evidence of extraperitoneal metastases at enrollment; * Resectable disease determined by radiological and laparoscopy/laparotomy; * No systematic therapy within 6 months before enrollment; * Tolerable to cytoreductive surgery. Exclusion Criteria: * Without adequate organ function (e.g. :neutrophil countt≤1.5×10\^9/L, or platelets≤75×10\^12/L，or hemoglobin\<90g/L, or aminotransferase、aspartate aminotransferaseAST\<2.5ULN, or total bilirubin\<1.5ULN, or creatinine\<1.5ULN; * Emergency surgery; * Recent thromboembolic event or cerebrovascular disease (12 months before enrollment); * Pregnancy or lactation * Comorbid with severe physical or mental disease.
References
Publications (0)
Data not yet available