Second Look Laparoscopy in Colorectal Cancer

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Treatments: Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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