Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
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|ClinicalTrials.gov Identifier: NCT00003652|
Recruitment Status : Unknown
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
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 or disease||Intervention/treatment||Phase|
|Anal Cancer||Drug: cisplatin Drug: fluorouracil Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 3|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Official Title:||Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study|
|Study Start Date :||January 1999|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003652
|Centre Paul Papin|
|Angers, France, 49036|
|Institut Sainte Catherine|
|Avignon, France, 84082|
|Bordeaux, France, 33076|
|CHU Ambroise Pare|
|Boulogne Billancourt, France, F-92104|
|C.H. Bourg En Bresse|
|Bourg En Bresse, France, 01012|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Chalon Sur Saone, France, F-71321|
|Hopital Louis Pasteur|
|Colmar, France, 68024|
|Centre Hospitalier Universitaire Henri Mondor|
|Creteil, France, 94010|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, F-85025|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Hospital Regional Universitaire de Limoges|
|Limoges, France, 87042|
|Centre Leon Berard|
|Lyon, France, 69373|
|Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|CHU de la Timone|
|Marseille, France, 13385|
|Hopital Clinique Claude Bernard|
|Metz, France, 57072|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Hospitalier de Mulhouse|
|Mulhouse, France, 68051|
|Centre D'Oncologie De Gentilly|
|Nancy, France, 54100|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|Centre Catherine de Sienne|
|Nante, France, 02|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|CHR D'Orleans - Hopital de la Source|
|Orleans, France, 45067|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Hopital Robert Debre|
|Paris, France, 75019|
|Institut Curie - Section Medicale|
|Paris, France, 75248|
|Paris, France, 75475|
|Paris, France, 75651|
|Paris, France, 75970|
|Hopital Jean Bernard|
|Poitiers, France, 86021|
|Clinique Ste - Marie|
|Pontoise, France, 95301|
|Institut Jean Godinot|
|Reims, France, 51056|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Hopital Charles Nicolle|
|Rouen, France, 76031|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Clinique Armoricaine De Radiologie|
|Saint Brieuc, France, F-22015|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Centre Hospitalier General de Saint Nazaire|
|Saint Nazaire, France, 44600|
|Clinique de l'Orangerie|
|Strasbourg, France, 67010|
|Centre Paul Strauss|
|Strasbourg, France, 67065|
|Centre Hospitalier Regional Metz Thionville|
|Thionville, France, 57126|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Tours, France, 37000|
|Nouvelle Clinique Generale|
|Valence, France, 26000|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Didier Peiffert, MD||Centre Alexis Vautrin|