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Sponsored by: |
Federation Nationale des Centres de Lutte Contre le Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003652 |
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.
Condition | Intervention | Phase |
Anal Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase III |
MedlinePlus related topics: | Anal Cancer Cancer |
ChemIDplus related topics: | Cisplatin Fluorouracil |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study |
Estimated Enrollment: | 350 |
Study Start Date: | January 1999 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study.
Patients are randomized to one of four treatment arms.
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.
Ages Eligible for Study: | up to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven nonmetastatic anal cancer
Stage II or III
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
France | |||||
C.H. Bourg En Bresse | |||||
Bourg En Bresse, France, 01012 | |||||
Centre Alexis Vautrin | |||||
Vandoeuvre-les-Nancy, France, 54511 | |||||
Centre Antoine Lacassagne | |||||
Nice, France, 06189 | |||||
Centre Catherine de Sienne | |||||
Nante, France, 02 | |||||
Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |||||
Dijon, France, 21079 | |||||
Centre D'Oncologie De Gentilly | |||||
Nancy, France, 54100 | |||||
Centre Eugene Marquis | |||||
Rennes, France, 35042 | |||||
Centre Henri Becquerel | |||||
Rouen, France, 76038 | |||||
Centre Hospital Regional Universitaire de Limoges | |||||
Limoges, France, 87042 | |||||
Centre Hospitalier de Mulhouse | |||||
Mulhouse, France, 68051 | |||||
Centre Hospitalier Departemental | |||||
La Roche Sur Yon, France, F-85025 | |||||
Centre Hospitalier General de Saint Nazaire | |||||
Saint Nazaire, France, 44600 | |||||
Centre Hospitalier Regional Metz Thionville | |||||
Thionville, France, 57126 | |||||
Centre Hospitalier Universitaire Henri Mondor | |||||
Creteil, France, 94010 | |||||
Centre Hospitalier | |||||
Chalon Sur Saone, France, F-71321 | |||||
Centre Leon Berard | |||||
Lyon, France, 69373 | |||||
Centre Oscar Lambret | |||||
Lille, France, 59020 | |||||
Centre Paul Papin | |||||
Angers, France, 49036 | |||||
Centre Paul Strauss | |||||
Strasbourg, France, 67065 | |||||
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |||||
Montpellier, France, 34298 | |||||
Centre Regional Francois Baclesse | |||||
Caen, France, 14076 | |||||
Centre Regional Rene Gauducheau | |||||
Nantes-Saint Herblain, France, 44805 | |||||
Centre Rene Huguenin | |||||
Saint Cloud, France, 92211 | |||||
CHR D'Orleans - Hopital de la Source | |||||
Orleans, France, 45067 | |||||
Nouvelle Clinique Generale | |||||
Valence, France, 26000 | |||||
CHU de la Timone | |||||
Marseille, France, 13385 | |||||
CHU Pitie-Salpetriere | |||||
Paris, France, 75651 | |||||
Clinique Armoricaine De Radiologie | |||||
Saint Brieuc, France, F-22015 | |||||
Clinique de l'Orangerie | |||||
Strasbourg, France, 67010 | |||||
Clinique Fleming | |||||
Tours, France, 37000 | |||||
Clinique Ste - Marie | |||||
Pontoise, France, 95301 | |||||
Hopital Bichat - Claude Bernard | |||||
Paris, France, 75018 | |||||
Hopital Charles Nicolle | |||||
Rouen, France, 76031 | |||||
Hopital Clinique Claude Bernard | |||||
Metz, France, 57072 | |||||
Hopital Europeen Georges Pompidou | |||||
Paris, France, 75015 | |||||
Hopital Jean Bernard | |||||
Poitiers, France, 86021 | |||||
Hopital Louis Pasteur | |||||
Colmar, France, 68024 | |||||
Hopital Robert Debre | |||||
Paris, France, 75019 | |||||
Hopital Saint-Louis | |||||
Paris, France, 75475 | |||||
Hopital Tenon | |||||
Paris, France, 75970 | |||||
Institut Bergonie | |||||
Bordeaux, France, 33076 | |||||
Institut Claudius Regaud | |||||
Toulouse, France, 31052 | |||||
Institut Curie - Section Medicale | |||||
Paris, France, 75248 | |||||
Institut Gustave Roussy | |||||
Villejuif, France, F-94805 | |||||
Institut J. Paoli and I. Calmettes | |||||
Marseille, France, 13273 | |||||
Institut Jean Godinot | |||||
Reims, France, 51056 | |||||
Institut Sainte Catherine | |||||
Avignon, France, 84082 | |||||
CHU Ambroise Pare | |||||
Boulogne Billancourt, France, F-92104 |
Federation Nationale des Centres de Lutte Contre le Cancer |
Study Chair: | Didier Peiffert, MD | Centre Alexis Vautrin |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000066744, FNCLCC-FFCD-SFRO-ACCORD-3, EU-98050 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003652 |
Health Authority: | United States: Federal Government |
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