Second Look Laparoscopy in Colorectal Cancer

NCT01628211 | Unknown Phase 2

• 1 other identifier: HIPEC
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

hyperthermic chemotherapy; intraperitoneal chemotherapy; second-look laparoscopy; peritoneal carcinosis; mucinous colorectal cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  two years

Secondary Outcomes (6)

• number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm

  6 months

• changes in quality of life

  6 months

• overall survival

  five years

• worst grade adverse event per patient

  7 months

• number of patients with radiologic evidence of disease after initial surgery

  6 months

Study Arms (2)

Second look laparoscopy

EXPERIMENTAL

Second look laparoscopy to evaluate for and treat peritoneal carcinosis

Procedure: Laparoscopy; Procedure: peritonectomy; Drug: Folinic Acid; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: systemic chemotherapy

standard follow up

NO INTERVENTION

Interventions

Laparoscopy PROCEDURE

second look laparoscopy to evaluate for peritoneal carcinosis

Second look laparoscopy

peritonectomy PROCEDURE

for patients with PCI \< 20

Second look laparoscopy

Folinic Acid DRUG

20 mg/m2 IV given just before HIPEC for patients with PCI \< 20

Second look laparoscopy

5-Fluorouracil DRUG

400 mg/m2 IV given just before HIPEC in patients with PCI \< 20

Second look laparoscopy

Oxaliplatin DRUG

460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI \< 20

Second look laparoscopy

systemic chemotherapy DRUG

according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI \> 20

Second look laparoscopy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico

Napoli, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Laparoscopy; Leucovorin; Fluorouracil; Oxaliplatin; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics

Study Officials

• C. Sassaroli, M.D.

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

• A Cassata, M.D.

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

• M.C. Piccirillo, M.D.

  NCI Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Perrone, M.D., Ph.D.

CONTACT

+39 081 5903571; francesco.perrone@usc-intnapoli.net

Marilina Piccirillo, M.D.

CONTACT

+39 081 5903383; marilina.piccirillo@usc-intnapoli.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 26, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (1)