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

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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

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.
    

Study Phase

Phase 3

Study Type

Interventional




Condition

Anal Cancer

Intervention

cisplatin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

350

Start Date

January 4, 1999

Completion Date

March 31, 2007

Primary Completion Date

April 1, 2006

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
      

Gender

All

Ages

N/A - 80 Years

Accepts Healthy Volunteers

No

Contacts

Didier Peiffert, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00003652

Organization ID

CDR0000066744

Secondary IDs

FNCLCC-FFCD-SFRO-ACCORD-3

Responsible Party

Sponsor

Study Sponsor

UNICANCER


Study Sponsor

Didier Peiffert, MD, Study Chair, Centre Alexis Vautrin


Verification Date

February 2021