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NCT00003596 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2017-01-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    cisplatin
    type
    DRUG
  2. name
    fluorouracil
    type
    DRUG
  3. name
    mitomycin C
    type
    DRUG
  4. name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
682
type
ACTUAL
Registered outcome plans (not posted results)
Full study description
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.
Source references
references
  1. citation
    Ben-Josef E, Moughan J, Ajani JA, Flam M, Gunderson L, Pollock J, Myerson R, Anne R, Rosenthal SA, Willett C. Impact of overall treatment time on survival and local control in patients with anal cancer: a pooled data analysis of Radiation Therapy Oncology Group trials 87-04 and 98-11. J Clin Oncol. 2010 Dec 1;28(34):5061-6. doi: 10.1200/JCO.2010.29.1351. Epub 2010 Oct 18.
    pmid
    20956625
    type
    BACKGROUND
  2. citation
    Glynne-Jones R, Mawdsley S. Anal cancer: is neoadjuvant cisplatin chemotherapy or chemoradiotherapy friend or foe? Nat Clin Pract Oncol. 2008 Dec;5(12):692-3. doi: 10.1038/ncponc1258. Epub 2008 Oct 14.
    pmid
    18852720
    type
    BACKGROUND
  3. citation
    Gunderson LL, Winter KA, Ajani JA, et al.: Long-term update of U.S. GI intergroup RTOG 98-11 phase III trial for anal carcinoma: disease-free and overall survival with RT+5FU-mitomycin versus RT+5FU-cisplatin. [Abstract] J Clin Oncol 29 (Suppl 15): A-4005, 2011.
    type
    RESULT
  4. citation
    Ajani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. Prognostic factors derived from a prospective database dictate clinical biology of anal cancer: the intergroup trial (RTOG 98-11). Cancer. 2010 Sep 1;116(17):4007-13. doi: 10.1002/cncr.25188.
    pmid
    20564111
    type
    RESULT
  5. citation
    Gunderson LL, Moughan J, Ajani JA, et al.: Anal carcinoma: Impact of TN category of disease on survival, disease relapse, and colostomy failure in U.S. GI Intergroup RTOG 98-11 phase III trial. [Abstract] American Society of Clinical Oncology 2010 Gastrointestinal Cancers Symposium, 22-24 January 2010, Orlando, Florida. A-285, 2010.
    type
    RESULT
  6. citation
    Ajani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. US intergroup anal carcinoma trial: tumor diameter predicts for colostomy. J Clin Oncol. 2009 Mar 1;27(7):1116-21. doi: 10.1200/JCO.2008.19.6857. Epub 2009 Jan 12.
    pmid
    19139424
    type
    RESULT
  7. citation
    Ajani JA, Winter KA, Gunderson LL, Pedersen J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett C. Fluorouracil, mitomycin, and radiotherapy vs fluorouracil, cisplatin, and radiotherapy for carcinoma of the anal canal: a randomized controlled trial. JAMA. 2008 Apr 23;299(16):1914-21. doi: 10.1001/jama.299.16.1914.
    pmid
    18430910
    type
    RESULT
  8. citation
    Ajani JA, Winter KA, Gunderson LL, et al.: Intergroup RTOG 98-11: a phase III randomized study of 5-fluorouracil (5-FU), mitomycin, and radiotherapy versus 5-fluorouracil, cisplatin and radiotherapy in carcinoma of the anal canal. [Abstract] J Clin Oncol 24 (Suppl 18): A-4009, 2006.
    type
    RESULT
  9. citation
    Gunderson LL, Winter KA, Ajani JA, et al.: Intergroup RTOG 9811 phase III comparison of chemoradiation with 5-FU and mitomycin vs 5-FU and cisplatin for anal canal carcinoma: impact on disease-free, overall and colostomy-free survival. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-43, S24, 2006.
    type
    RESULT
  10. citation
    Gunderson LL, Winter KA, Ajani JA, Pedersen JE, Moughan J, Benson AB 3rd, Thomas CR Jr, Mayer RJ, Haddock MG, Rich TA, Willett CG. Long-term update of US GI intergroup RTOG 98-11 phase III trial for anal carcinoma: survival, relapse, and colostomy failure with concurrent chemoradiation involving fluorouracil/mitomycin versus fluorouracil/cisplatin. J Clin Oncol. 2012 Dec 10;30(35):4344-51. doi: 10.1200/JCO.2012.43.8085. Epub 2012 Nov 13.
    pmid
    23150707
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        of cisplatin for mitomycin, with differing conclusions. </p></li><li>In a phase III U.S. Intergroup trial (<a href="/clinicaltrials/NCT00003596">RTOG 9811</a> [NCT00003596]), patients in the cisplatin arm received two cycles of induction 5-FU and cisplatin before receiving concurrent chemoradiation therapy with 5-FU and cisplati
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      source title
      Anal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
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        display
        February 12, 2025

    Preserved source evidence · Not medical advice