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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Anal Cancer Drug: cisplatin Drug: fluorouracil Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study
Study Start Date : January 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 80 and under

Performance status:

  • WHO 0 or 1

Life expectancy:

  • Not specified


  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 11 g/dL (transfusion allowed)


  • Not specified


  • Creatinine no greater than 1.5 mg/dL


  • No cardiac condition contraindicating use of fluorouracil


  • 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


Biologic therapy:

  • No prior biologic therapy


  • No prior chemotherapy

Endocrine therapy:

  • No prior endocrine therapy


  • No prior pelvic or inguinal radiotherapy


  • See Disease Characteristics
  • No prior definitive colostomy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003652

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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
Sponsors and Collaborators
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Study Chair: Didier Peiffert, MD Centre Alexis Vautrin

Publications of Results:
Layout table for additonal information Identifier: NCT00003652     History of Changes
Other Study ID Numbers: CDR0000066744
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: May 2005
Keywords provided by National Cancer Institute (NCI):
stage II anal cancer
stage III anal cancer
squamous cell carcinoma of the anus
cloacogenic carcinoma of the anus
basaloid carcinoma of the anus
Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs