Clinical trial · Interventional
Second Look Laparoscopy in Colorectal Cancer
Randomized Phase 2 Study Comparing Second Look Laparoscopy to Standard Follow up in Patients With no Radiologic Evidence of Disease at 6 Months After Complete Resection of Colorectal Mucinous Carcinoma
- 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)
The purpose of this study is to evaluate whether a second-look laparoscopy, followed by peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in case of peritoneal carcinosis, improves the overall survival of patients who have had radical resection of mucinous colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Folinic Acid | Drug | — | UNRESOLVED |
| Laparoscopy | Procedure | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| peritonectomy | Procedure | — | UNRESOLVED |
| systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Second look laparoscopy
- description
- Second look laparoscopy to evaluate for and treat peritoneal carcinosis
- interventionNames
- Procedure: Laparoscopy
- Procedure: peritonectomy
- Drug: Folinic Acid
- Drug: 5-Fluorouracil
- Drug: Oxaliplatin
- Drug: systemic chemotherapy
- type
- NO_INTERVENTION
- label
- standard follow up
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- two years
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis colorectal adenocarcinoma * Mucinous histotype * Stage I-III * Radical (R0) surgical resection of primary tumor * CT scan with contrast showing no evidence of disease recurrence 6 months after primary surgery * Age ≥ 18 ≤ 65 years * Performance Status ECOG ≤1 * Normal hepatic, renal and hematologic function * Adjuvant chemotherapy permitted * Signed informed consent Exclusion Criteria: * Residual disease after surgical resection of primary tumor * Distant metastasis * Active systemic infection * Chronic cardiovascular illness that would contraindicate abdominal dilatation with pneumoperitoneum * Concomitant or previous malignancy with 5 years of surgical resection of primary tumor (except for adequately treated non-melanoma skin cancer and in situ cervical cancer) * Pregnancy or lactation * Refusal or incapability of providing informed consent * Impossibility of complying with study schedules and follow-up
References
Publications (0)
Data not yet available