Clinical trial · Interventional
Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
A Phase III Randomized Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy Versus 5-Fluorouracil, Cisplatin, and Radiotherapy in Carcinoma of the Anal Canal
NCT00003596CI-TRIAL-00025335completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| mitomycin C | Drug | Mitomycin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDBen-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
- BACKGROUNDGlynne-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
- RESULTGunderson 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.
- RESULTAjani 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
- RESULTGunderson 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.
- RESULTAjani 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
- RESULTAjani 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.