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Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study (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.
  • Drug: cisplatin
    • Drug: fluorouracil
      • Procedure: neoadjuvant therapy
        • Radiation: radiation therapy
          Ages eligible for Study
          up to 80 Years
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          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.

          48 locations

          France (48)
          • Centre Paul Papin
            Angers, France, 49036
          • Institut Sainte Catherine
            Avignon, France, 84082
          • Institut Bergonie
            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
          • Centre Hospitalier
            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
          • Hopital Saint-Louis
            Paris, France, 75475
          • CHU Pitie-Salpetriere
            Paris, France, 75651
          • Hopital Tenon
            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
          • Clinique Fleming
            Tours, France, 37000
          • Nouvelle Clinique Generale
            Valence, France, 26000
          • Centre Alexis Vautrin
            Vandoeuvre-les-Nancy, France, 54511
          • Institut Gustave Roussy
            Villejuif, France, F-94805
          Status:
          unknown
          Type:
          Interventional
          Phase:
          Start:
          31 December, 1998
          Updated:
          05 February, 2009
          Participants:
          350
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