Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer

Phase 2

Terminated

• Conditions: Anal Cancer

• Registration Number: NCT00955240
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab may kill more tumor cells.

PURPOSE: This phase II trial is studying giving radiation therapy together with cisplatin, fluorouracil, and cetuximab to see how well it works in treating patients with locally advanced anal cancer.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the objective response (complete and partial) 8 weeks after completion of study treatment comprising radiotherapy, chemotherapy (fluorouracil and cisplatin), and cetuximab followed by additional radiotherapy in patients with locally advanced anal cancer.

Secondary

* Evaluate colostomy-free survival.

* Evaluate the local control rate (objective response and stabilization) at 8 weeks.

* Evaluate relapse-free survival at 5 years.

* Evaluate the intermediate objective response at the end of week 5 of radiotherapy.

* Evaluate overall survival at 5 years.

* Evaluate the duration of response.

* Evaluate acute toxicities according to CTCAE v3.0.

* Evaluate late toxicities at 5 years according to CTCAE v3.0.

* Study the tumor markers associated with response (survival without relapse) and toxicity.

* Study the genotypes of Fc-receptor immunoglobulins (FCGR2A and FCGR3) and their association with skin toxicity, objective survival, and relapse-free survival.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV on days 0, 7, 14, 21, 28, and 35; fluorouracil IV on days 7-10 and 35-38; and cisplatin IV over 2 hours on days 7 and 35. Beginning on day 7, patients also undergo radiotherapy 5 days a week for 5 weeks (weeks 2-6). Two weeks after finishing this treatment, patients undergo additional radiotherapy\* 5 days a week for 2 weeks (weeks 9 and 10).

NOTE: \*Some patients may undergo brachytherapy.

Blood and tissue samples are collected for further analysis.

After completion of study treatment, patients are followed up for 4 years.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-07
• Study First Posted: 2009-08-10
• Primary Completion: 2010-11-26
• Study Completion: 2010-11-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective response (complete and partial) according to RECIST criteria at 8 weeks after completion of study treatment

Secondary Outcome Measures

Name	Time	Method
Survival rate at 3 and 5 years
Colostomy-free survival at 3 and 5 years
Duration of objective response

Trial Locations

Locations (20)

Centre Regional Rene Gauducheau; 🇫🇷 Nantes-Saint Herblain, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Groupe Oncorad Garonne; 🇫🇷 Toulouse, France

Hopital Saint-Louis; 🇫🇷 Paris, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre-les-Nancy, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Hospitalier Departemental; 🇫🇷 La Roche Sur Yon, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France

Hopital Tenon; 🇫🇷 Paris, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Hospital Regional Universitaire de Limoges; 🇫🇷 Limoges, France

Institut Curie Hopital; 🇫🇷 Paris, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Hopital Charles Nicolle; 🇫🇷 Rouen, France

Clinique Du Parc; 🇫🇷 Toulouse, France

Centre Hospitalier Prive Saint-Gregoire; 🇫🇷 Saint-Gregoire, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

CHU Hopital A. Morvan; 🇫🇷 Brest, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France