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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- overall survival
Study Overview
Brief 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.
Detailed Description
Patients will be entered into the study after radical resection of mucinous colorectal cancer, and reevaluated by CT scan after 6 months. Patients with no evidence of disease will be randomized to receive either standard follow up, or to have a second look laparoscopy to evaluate for peritoneal carcinosis. After laparoscopy, those patients who do not have peritoneal carcinosis will continue with standard follow up. Patients with peritoneal carcinosis diagnosed by laparoscopy will be treated according to their peritoneal carcinosis index (PCI). For patients with PCI > 20, systemic chemotherapy will be given according to Italian Association of Medical Oncology (AIOM) guidelines. Patients with PCI < 20 will undergo peritonectomy and then receive intravenous chemotherapy immediately followed by HIPEC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Second look laparoscopy
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Intervention: Laparoscopy (Procedure)
Second look laparoscopy
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Intervention: peritonectomy (Procedure)
Second look laparoscopy
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Intervention: Folinic Acid (Drug)
Second look laparoscopy
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Intervention: 5-Fluorouracil (Drug)
Second look laparoscopy
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Intervention: Oxaliplatin (Drug)
Second look laparoscopy
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Intervention: systemic chemotherapy (Drug)
Outcomes
Primary Outcomes
overall survival
Time Frame: two years
Secondary Outcomes
- overall survival(five years)
- changes in quality of life(6 months)
- worst grade adverse event per patient(7 months)
- number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm(6 months)
- list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery(two years)
- number of patients with radiologic evidence of disease after initial surgery(6 months)