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
Recruitment status was Active, not recruiting
Sponsor:
UNICANCER
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
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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 |
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
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 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Institut J. Paoli and I. Calmettes | |
| Marseille, France, 13273 | |
| 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 | |
| CHU Pitie-Salpetriere | |
| Paris, France, 75651 | |
| Hopital Robert Debre | |
| Paris, France, 75019 | |
| Hopital Europeen Georges Pompidou | |
| Paris, France, 75015 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hopital Bichat - Claude Bernard | |
| Paris, France, 75018 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| Institut Curie - Section Medicale | |
| Paris, France, 75248 | |
| 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 Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |
Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 21, 2013