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

Anal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003652
• Other study ID #: CDR0000066744
• Secondary ID: FNCLCC-FFCD-SFRO
• Status: Completed
• Phase: Phase 3
• Start date: January 4, 1999
• Est. completion date: March 31, 2007

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: March 31, 2007
• Est. primary completion date: April 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Procedure:
• neoadjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	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 Saone
France	Hopital Louis Pasteur	Colmar
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
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	CHU de la Timone	Marseille
France	Institut J. Paoli and I. Calmettes	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	Nante
France	Centre Regional Rene Gauducheau	Nantes-Saint Herblain
France	Centre Antoine Lacassagne	Nice
France	CHR D'Orleans - Hopital de la Source	Orleans
France	CHU Pitie-Salpetriere	Paris
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Robert Debre	Paris
France	Hopital Saint-Louis	Paris
France	Hopital Tenon	Paris
France	Institut Curie - Section Medicale	Paris
France	Hopital Jean Bernard	Poitiers
France	Clinique Ste - Marie	Pontoise
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Hopital Charles Nicolle	Rouen
France	Clinique Armoricaine De Radiologie	Saint Brieuc
France	Centre Rene Huguenin	Saint Cloud
France	Centre Hospitalier General de Saint Nazaire	Saint Nazaire
France	Centre Paul Strauss	Strasbourg
France	Clinique de l'Orangerie	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	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (1)

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 ACC — View Citation