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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003652
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: May 2005
  Purpose

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
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 350
Study Start Date: January 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003652

Locations
France
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 Catherine de Sienne
Nante, France, 02
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
CHR D'Orleans - Hopital de la Source
Orleans, France, 45067
Hopital Robert Debre
Paris, France, 75019
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Saint-Louis
Paris, France, 75475
Hopital Tenon
Paris, France, 75970
Institut Curie - Section Medicale
Paris, France, 75248
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Jean Bernard
Poitiers, France, 86021
Clinique Ste - Marie
Pontoise, France, 95301
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35042
Centre Henri Becquerel
Rouen, France, 76038
Hopital Charles Nicolle
Rouen, France, 76031
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
Centre Paul Strauss
Strasbourg, France, 67065
Clinique de l'Orangerie
Strasbourg, France, 67010
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
UNICANCER
Investigators
Study Chair: Didier Peiffert, MD Centre Alexis Vautrin
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00003652     History of Changes
Other Study ID Numbers: CDR0000066744, FNCLCC-FFCD-SFRO-ACCORD-3, EU-98050
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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:
Anus Neoplasms
Anus Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Rectal Neoplasms
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014