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

Learn more about:
Related Clinical Trial
CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers Assessment of Patients’ Quality of Sexual Life After Anal Cancer Treatment Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5) Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors Detecting HPV DNA in Anal and Cervical Cancers ANCA II – Quality of Life and Functional Outcome in Patients With Anal Cancer RTX-321 Monotherapy in Patients With HPV 16+ Tumors Anal Injury Screening for High Risk HPV M7824 in Subjects With HPV Associated Malignancies Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies Function Following Laser for Anal Intraepithelial Neoplasia (FLAN) A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula HPV-SAVE: 9-Valent HPV Vaccine for High-Grade Anal Dysplasia Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men High-Resolution Anoscopy Perceived Discomfort Study Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia Image Fusion PET, CT and 3D-ultrasound Examinations Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV Molecular Genetic and Pathological Studies of Anal Tumors Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy Screening for HIV-Associated Anal Cancer Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE) Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer Prospective Cohort on Quality of Sexual Life Among Men Who Have Sex With Men Treated for Anal Cancer With Concurrent Chemotherapy and Intensity-modulated Radiotherapy Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Anal Cancer Radiotherapy Study Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer Individual Following in Anal Cancer With PET/CT Anal Cancer Screening Study The Prevent Anal Cancer Self-Swab Study Shared Decision Making With Anal Cancer Patients on Radiation Dose Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy Quality of Life in Patients With Anal Cancer Functional Outcomes Following Anal Cancer Treatment Pembrolizumab in Refractory Metastatic Anal Cancer A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

Brief Title

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

Official Title

A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin, and Radiotherapy in Carcinoma of the Anal Canal

Brief Summary

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug or combining radiation therapy with
      chemotherapy may kill more tumor cells. It is not yet known whether fluorouracil and
      mitomycin plus radiation therapy is more effective than fluorouracil and cisplatin plus
      radiation therapy for anal cancer.

      PURPOSE: This randomized phase III trial is studying fluorouracil and mitomycin plus
      radiation therapy to see how well it works compared to fluorouracil and cisplatin plus
      radiation therapy in treating patients with stage II or stage III anal cancer.
    

Detailed Description

      OBJECTIVES:

        -  Compare the initial and total local and distant failure rates in patients with anal
           canal cancer treated with either fluorouracil (5-FU) plus mitomycin concurrently with
           radiotherapy or 5-FU plus cisplatin followed by 5-FU plus cisplatin concurrently with
           radiotherapy.

        -  Identify any differences in local control and colostomy rates at 2 years in patients
           treated with these regimens.

        -  Determine any difference in colostomy free, disease free, or overall survival in
           patients treated with these regimens.

        -  Compare the toxic effects of these regimens in these patients.

        -  Evaluate the prognostic effects of tumor markers P53 overexpression, human papilloma
           virus status, and enzyme HAP1 in patients treated with these regimens.

      OUTLINE: This is a randomized study. Patients are stratified according to gender, nodal
      status (positive vs negative), and primary tumor size (greater than 2 cm to 5 cm vs greater
      than 5 cm). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive fluorouracil (5-FU) IV continuously over 96 hours beginning on
           days 1 and 29 and mitomycin IV on days 1 and 29 with concurrent radiotherapy.

        -  Arm II: Patients receive induction chemotherapy comprising 5-FU IV continuously over 96
           hours beginning on days 1, 29, 57, and 85 and cisplatin IV over 1 hour on days 1, 29,
           57, and 85. Beginning on day 57, patients receive concurrent radiotherapy.

      In both arms, radiotherapy is administered daily, 5 days a week, for 5-6.5 weeks. Patients
      with T3, T4, or N+ lesions or T2 lesions with residual disease receive additional
      radiotherapy to a reduced field.

      Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually
      thereafter.

      PROJECTED ACCRUAL: A total of 650 patients will be accrued for this study within 5 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

682

Start Date

October 1998

Completion Date

December 2016

Primary Completion Date

October 2005

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary squamous, basaloid, or cloacogenic carcinoma of the
             anal canal, other than carcinoma in situ

               -  T2-4, Any N, M0 (stage II or III)

          -  No local or regional recurrence after local excision or abdominal peritoneal resection

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 60-100%

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  WBC at least 4,000/mm^3

          -  Absolute neutrophil count at least 1,800/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 10 g/dL

        Hepatic:

          -  Bilirubin less than 1.4 mg/dL

        Renal:

          -  Creatinine no greater than 1.5 mg/dL OR

          -  Creatinine clearance at least 80 mL/min

        Cardiovascular:

          -  No uncompensated heart disease

          -  No uncontrolled high blood pressure

        Other:

          -  No AIDS

          -  No active systemic infection

          -  No uncontrolled diabetes

          -  No other prior malignancy within the past 5 years except nonmelanoma skin cancer

          -  No mental condition that would preclude study participation

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Prior epoetin alfa allowed in lieu of blood transfusions

        Chemotherapy:

          -  At least 5 years since prior chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  At least 5 years since prior radiotherapy

        Surgery:

          -  No prior surgery of anal canal except for biopsy of study site
      

Gender

All

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Jaffer A. Ajani, MD, , 

Location Countries

South Africa

Location Countries

South Africa

Administrative Informations


NCT ID

NCT00003596

Organization ID

RTOG-9811

Secondary IDs

CDR0000066667

Responsible Party

Sponsor

Study Sponsor

Radiation Therapy Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Jaffer A. Ajani, MD, Study Chair, M.D. Anderson Cancer Center


Verification Date

December 2016