Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
NCT ID: NCT00003652
Last Updated: 2021-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
1999-01-04
2007-03-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
fluorouracil
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
0 Years
80 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Didier Peiffert, MD
Role: STUDY_CHAIR
Centre Alexis Vautrin
Locations
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Centre Paul Papin
Angers, , France
Institut Sainte Catherine
Avignon, , France
Institut Bergonie
Bordeaux, , France
CHU Ambroise Pare
Boulogne-Billancourt, , France
C.H. Bourg En Bresse
Bourg-en-Bresse, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Hospitalier
Chalon-sur-Saône, , France
Hopital Louis Pasteur
Colmar, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Centre Oscar Lambret
Lille, , France
Centre Hospital Regional Universitaire de Limoges
Limoges, , France
Centre Leon Berard
Lyon, , France
Institut J. Paoli and I. Calmettes
Marseille, , France
CHU de la Timone
Marseille, , France
Hopital Clinique Claude Bernard
Metz, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Centre D'Oncologie De Gentilly
Nancy, , France
Centre Catherine de Sienne
Nantes, , France
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, , France
Centre Antoine Lacassagne
Nice, , France
CHR D'Orleans - Hopital de la Source
Orléans, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Bichat - Claude Bernard
Paris, , France
Hopital Robert Debre
Paris, , France
Institut Curie - Section Medicale
Paris, , France
Hopital Saint-Louis
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Tenon
Paris, , France
Hopital Jean Bernard
Poitiers, , France
Clinique Ste - Marie
Pontoise, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Hopital Charles Nicolle
Rouen, , France
Centre Henri Becquerel
Rouen, , France
Clinique Armoricaine De Radiologie
Saint-Brieuc, , France
Centre Rene Huguenin
Saint-Cloud, , France
Centre Hospitalier General de Saint Nazaire
Saint-Nazaire, , France
Clinique de l'Orangerie
Strasbourg, , France
Centre Paul Strauss
Strasbourg, , France
Centre Hospitalier Regional Metz Thionville
Thionville, , France
Institut Claudius Regaud
Toulouse, , France
Clinique Fleming
Tours, , France
Nouvelle Clinique Generale
Valence, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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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.
Other Identifiers
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FNCLCC-FFCD-SFRO-ACCORD-3
Identifier Type: -
Identifier Source: secondary_id
EU-98050
Identifier Type: -
Identifier Source: secondary_id
CDR0000066744
Identifier Type: -
Identifier Source: org_study_id
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