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

February 15, 2021 updated by: UNICANCER

Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49036
        • Centre Paul Papin
      • Avignon, France, 84082
        • Institut Sainte Catherine
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Boulogne Billancourt, France, F-92104
        • CHU Ambroise Pare
      • Bourg En Bresse, France, 01012
        • C.H. Bourg En Bresse
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Chalon Sur Saone, France, F-71321
        • Centre Hospitalier
      • Colmar, France, 68024
        • Hôpital Louis Pasteur
      • Creteil, France, 94010
        • Centre Hospitalier Universitaire Henri Mondor
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • La Roche Sur Yon, France, F-85025
        • Centre Hospitalier departemental
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Limoges, France, 87042
        • Centre Hospital Regional Universitaire de Limoges
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13385
        • CHU de la Timone
      • Marseille, France, 13273
        • Institut J. Paoli and I. Calmettes
      • Metz, France, 57072
        • Hopital Clinique Claude Bernard
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Mulhouse, France, 68051
        • Centre Hospitalier de Mulhouse
      • Nancy, France, 54100
        • Centre d'Oncologie de Gentilly
      • Nante, France, 02
        • Centre Catherine de Sienne
      • Nantes-Saint Herblain, France, 44805
        • Centre Regional Rene Gauducheau
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Orleans, France, 45067
        • CHR D'Orleans - Hopital de la Source
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75018
        • Hôpital Bichat - Claude Bernard
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75019
        • Hopital Robert Debre
      • Paris, France, 75248
        • Institut Curie - Section Medicale
      • Paris, France, 75475
        • Hôpital Saint-Louis
      • Poitiers, France, 86021
        • Hopital Jean Bernard
      • Pontoise, France, 95301
        • Clinique Ste - Marie
      • Reims, France, 51056
        • Institut Jean Godinot
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Rouen, France, 76031
        • Hopital Charles Nicolle
      • Saint Brieuc, France, F-22015
        • Clinique Armoricaine de Radiologie
      • Saint Cloud, France, 92211
        • Centre René Huguenin
      • Saint Nazaire, France, 44600
        • Centre Hospitalier General de Saint Nazaire
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Strasbourg, France, 67010
        • Clinique de l'Orangerie
      • Thionville, France, 57126
        • Centre Hospitalier Regional Metz Thionville
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Tours, France, 37000
        • Clinique Fleming
      • Valence, France, 26000
        • Nouvelle Clinique Generale
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, F-94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Didier Peiffert, MD, Centre Alexis Vautrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 1999

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

March 31, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066744
  • FNCLCC-FFCD-SFRO-ACCORD-3
  • EU-98050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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