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

Primary Purpose

Anal Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
cisplatin
fluorouracil
neoadjuvant therapy
radiation therapy
Sponsored by
UNICANCER
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Cancer focused on measuring stage II anal cancer, stage III anal cancer, squamous cell carcinoma of the anus, cloacogenic carcinoma of the anus, basaloid carcinoma of the anus

Eligibility Criteria

0 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Institut Sainte Catherine
  • Institut Bergonie
  • CHU Ambroise Pare
  • C.H. Bourg En Bresse
  • Centre Regional Francois Baclesse
  • Centre Hospitalier
  • Hopital Louis Pasteur
  • Centre Hospitalier Universitaire Henri Mondor
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • Centre Hospitalier Departemental
  • Centre Oscar Lambret
  • Centre Hospital Regional Universitaire de Limoges
  • Centre Leon Berard
  • Institut J. Paoli and I. Calmettes
  • CHU de la Timone
  • Hopital Clinique Claude Bernard
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Hospitalier de Mulhouse
  • Centre D'Oncologie De Gentilly
  • Centre Regional Rene Gauducheau
  • Centre Catherine de Sienne
  • Centre Antoine Lacassagne
  • CHR D'Orleans - Hopital de la Source
  • Hopital Europeen Georges Pompidou
  • Hopital Bichat - Claude Bernard
  • Hopital Robert Debre
  • Institut Curie - Section Medicale
  • Hopital Saint-Louis
  • CHU Pitie-Salpetriere
  • Hopital Tenon
  • Hopital Jean Bernard
  • Clinique Ste - Marie
  • Institut Jean Godinot
  • Centre Eugene Marquis
  • Hopital Charles Nicolle
  • Centre Henri Becquerel
  • Clinique Armoricaine De Radiologie
  • Centre Rene Huguenin
  • Centre Hospitalier General de Saint Nazaire
  • Clinique de l'Orangerie
  • Centre Paul Strauss
  • Centre Hospitalier Regional Metz Thionville
  • Institut Claudius Regaud
  • Clinique Fleming
  • Nouvelle Clinique Generale
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 15, 2021
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00003652
Brief Title
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Official Title
Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 1999 (Actual)
Primary Completion Date
April 1, 2006 (Actual)
Study Completion Date
March 31, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer
Keywords
stage II anal cancer, stage III anal cancer, squamous cell carcinoma of the anus, cloacogenic carcinoma of the anus, basaloid carcinoma of the anus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Peiffert, MD
Organizational Affiliation
Centre Alexis Vautrin
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49036
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
C.H. Bourg En Bresse
City
Bourg En Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier
City
Chalon Sur Saone
ZIP/Postal Code
F-71321
Country
France
Facility Name
Hopital Louis Pasteur
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
F-85025
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Clinique Claude Bernard
City
Metz
ZIP/Postal Code
57072
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
Centre D'Oncologie De Gentilly
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Centre Regional Rene Gauducheau
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Catherine de Sienne
City
Nante
ZIP/Postal Code
02
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
CHR D'Orleans - Hopital de la Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Bichat - Claude Bernard
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Hopital Robert Debre
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Institut Curie - Section Medicale
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Hopital Jean Bernard
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Clinique Ste - Marie
City
Pontoise
ZIP/Postal Code
95301
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Clinique Armoricaine De Radiologie
City
Saint Brieuc
ZIP/Postal Code
F-22015
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
Centre Hospitalier General de Saint Nazaire
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67010
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Centre Hospitalier Regional Metz Thionville
City
Thionville
ZIP/Postal Code
57126
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Clinique Fleming
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Nouvelle Clinique Generale
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18191265
Citation
Tournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. doi: 10.1016/j.radonc.2007.12.004. Epub 2008 Jan 11.
Results Reference
result

Learn more about this trial

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

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