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

NCT00003652 | Completed Phase 3 DMC

• 3 other identifiers: CDR0000066744FNCLCC-FFCD-SFRO-ACCORD-3EU-98050
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 48

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.

Conditions

Anal Cancer

Keywords

stage II anal cancer; stage III anal cancer; squamous cell carcinoma of the anus; cloacogenic carcinoma of the anus; basaloid carcinoma of the anus

Interventions

cisplatin DRUG

fluorouracil DRUG

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 0 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven nonmetastatic anal cancer * Anal/rectal junction OR * Anal/cutaneous junction with the majority of the tumor in the anal canal, above the junction * Epidermoid cancer (well-differentiated, fairly differentiated, or basaloid) OR * Cloacogenic cancer * Stage II or III * T2 at least 4 cm OR * T3 OR * T4, N0-3, M0 OR * T1, N1-3 OR * T2 (less than 4 cm), N1-3 * Tumors at least 4 cm in greatest dimension and/or tumors with lymph node invasion must be nonmetastatic by ultrasound * No prior surgery to remove tumor PATIENT CHARACTERISTICS: Age: * 80 and under Performance status: * WHO 0 or 1 Life expectancy: * Not specified Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 11 g/dL (transfusion allowed) Hepatic: * Not specified Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No cardiac condition contraindicating use of fluorouracil Other: * No prior malignancy within 5 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or breast * No other serious medical or psychological condition * No serious immunosuppression PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy Chemotherapy: * No prior chemotherapy Endocrine therapy: * No prior endocrine therapy Radiotherapy: * No prior pelvic or inguinal radiotherapy Surgery: * See Disease Characteristics * No prior definitive colostomy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (48)

Centre Paul Papin

Angers, 49036, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

CHU Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

C.H. Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre Hospitalier

Chalon-sur-Saône, F-71321, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Hopital Clinique Claude Bernard

Metz, 57072, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Centre D'Oncologie De Gentilly

Nancy, 54100, France

Location

Centre Catherine de Sienne

Nantes, 02, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Robert Debre

Paris, 75019, France

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Hopital Saint-Louis

Paris, 75475, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hopital Jean Bernard

Poitiers, 86021, France

Location

Clinique Ste - Marie

Pontoise, 95301, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Centre Hospitalier General de Saint Nazaire

Saint-Nazaire, 44600, France

Location

Clinique de l'Orangerie

Strasbourg, 67010, France

Location

Centre Paul Strauss

Strasbourg, 67065, France

Location

Centre Hospitalier Regional Metz Thionville

Thionville, 57126, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Clinique Fleming

Tours, 37000, France

Location

Nouvelle Clinique Generale

Valence, 26000, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (1)

• Tournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. doi: 10.1016/j.radonc.2007.12.004. Epub 2008 Jan 11.

  PMID: 18191265 RESULT

MeSH Terms

Conditions

Anus Neoplasms; Anal Canal Carcinoma

Interventions

Cisplatin; Fluorouracil; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics

Study Officials

• Didier Peiffert, MD

  Centre Alexis Vautrin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 4, 1999
• Primary Completion: April 1, 2006
• Study Completion: March 31, 2007
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

FR (48)