Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer

Phase 3

Completed

• Conditions: Anal Cancer

• Registration Number: NCT00003652
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: This randomized phase III trial is studying different regimens of giving combination chemotherapy together with radiation therapy and comparing how well they work in treating patients with stage II or stage III anal cancer.

Detailed Description

OBJECTIVES:

* Compare the efficacy of concurrent chemotherapy and radiotherapy with or without neoadjuvant chemotherapy with fluorouracil and cisplatin in patients with stage II or III anal canal cancer.

* Compare the efficacy of two levels of radiation dose in patients with stage II or III anal canal cancer.

* Compare the sphincter conservation of the anus by these regimens.

* Compare the effect of these regimens on survival and quality of life of these patients.

OUTLINE: This is a randomized, multicenter study.

Patients are randomized to one of four treatment arms.

* Arm I: Patients receive induction chemotherapy consisting of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 every 4 weeks for 2 courses. Beginning 4 weeks later, patients receive chemoradiotherapy. This regimen consists of fluorouracil IV over 24 hours on days 1-4 and cisplatin IV over 1 hour on day 1 or 2 and repeated 4 weeks later, plus pelvic radiotherapy beginning on day 1 and continuing for 5 weeks (once a day, 5 days/week). Patients receive low dose radiotherapy directly to the tumor beginning 3 weeks later and continuing for 2 weeks.

* Arm II: Patients receive induction chemotherapy and chemoradiotherapy as in arm I, plus high dose radiotherapy directly to the tumor.

* Arm III (control arm): Patients receive chemoradiotherapy and low dose radiotherapy to the tumor as in arm I.

* Arm IV: Patients receive chemoradiotherapy and high dose radiotherapy to the tumor as in arm II.

After study treatment is completed, patients with nonfixed inguinal tumors may undergo surgical resection followed by radiotherapy or radiotherapy alone. Patients with fixed inguinal tumors may receive further radiotherapy alone.

Quality of life is assessed before treatment, at 2 months after completion of treatment, and at 5 years.

Patients are followed every 4 months for 2 years, every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 4 years.

Study Timeline

• Study Start: 1999-01-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-04-01
• Study Completion: 2007-03-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (48)

Centre Paul Papin; 🇫🇷 Angers, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

Centre Hospitalier; 🇫🇷 Chalon Sur Saone, France

C.H. Bourg En Bresse; 🇫🇷 Bourg En Bresse, France

Centre Hospitalier Universitaire Henri Mondor; 🇫🇷 Creteil, France

Hopital Robert Debre; 🇫🇷 Paris, France

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

Clinique Armoricaine De Radiologie; 🇫🇷 Saint Brieuc, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Institut Bergonie; 🇫🇷 Bordeaux, France

CHU Ambroise Pare; 🇫🇷 Boulogne Billancourt, France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc; 🇫🇷 Dijon, France

Hopital Louis Pasteur; 🇫🇷 Colmar, France

Centre Oscar Lambret; 🇫🇷 Lille, France

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

Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

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

Centre Leon Berard; 🇫🇷 Lyon, France

Hopital Clinique Claude Bernard; 🇫🇷 Metz, France

Centre Hospitalier de Mulhouse; 🇫🇷 Mulhouse, France

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

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre Catherine de Sienne; 🇫🇷 Nante, France

CHR D'Orleans - Hopital de la Source; 🇫🇷 Orleans, France

Hopital Bichat - Claude Bernard; 🇫🇷 Paris, France

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

Institut Curie - Section Medicale; 🇫🇷 Paris, France

Hopital Saint-Louis; 🇫🇷 Paris, France

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Hopital Jean Bernard; 🇫🇷 Poitiers, France

Institut Jean Godinot; 🇫🇷 Reims, France

Clinique Ste - Marie; 🇫🇷 Pontoise, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Hopital Charles Nicolle; 🇫🇷 Rouen, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Hospitalier Regional Metz Thionville; 🇫🇷 Thionville, France

Centre Rene Huguenin; 🇫🇷 Saint Cloud, France

Centre Hospitalier General de Saint Nazaire; 🇫🇷 Saint Nazaire, France

Clinique de l'Orangerie; 🇫🇷 Strasbourg, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

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

Nouvelle Clinique Generale; 🇫🇷 Valence, France

Clinique Fleming; 🇫🇷 Tours, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

CHU de la Timone; 🇫🇷 Marseille, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre D'Oncologie De Gentilly; 🇫🇷 Nancy, France