Clinical trial · Interventional
Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer
Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer . PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced 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 |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Response as measured by RECIST at 8 weeks after completion of study treatment (Phase II)
- measure
- Event-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
Secondary outcomes (7)
- measure
- Acute toxicity and compliance to treatment as measured by CTC v 2.0 at completion of study treatment (Phase II)
- measure
- Colostomy-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter (Phase III)
- measure
- Overall survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
- measure
- Disease-free survival as measured by Logrank at 12 and 26 weeks, then every 6 months thereafter
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell anal carcinoma
* Keratinizing or non-keratinizing
* The following stages are eligible:
* T2, N0, M0 with maximum tumor diameter at least 4 cm
* T3-T4, N0, M0
* Any T, N1-N3, M0
* Tumor located in the anal canal OR in the anal margin and infiltrating the anal canal
* No primary adenocarcinoma of the anus
* Measurable disease
PATIENT CHARACTERISTICS:
Age
* 18 to 75
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count greater than 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic
* Not specified
Renal
* Creatinine less than 1.4 mg/dL
Cardiovascular
* No grade I angina pectoris with clinical symptoms within the past 3 months
* No grade II-IV angina pectoris within the past 3 months
* No stage II or greater distal arteritis
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No other concurrent radiotherapy
Surgery
* No prior colostomy
Other
* No prior treatment for anal cancerReferences
Publications (1)
- RESULTMatzinger O, Roelofsen F, Mineur L, Koswig S, Van Der Steen-Banasik EM, Van Houtte P, Haustermans K, Radosevic-Jelic L, Mueller RP, Maingon P, Collette L, Bosset JF; EORTC Radiation Oncology and Gastrointestinal Tract Cancer Groups. Mitomycin C with continuous fluorouracil or with cisplatin in combination with radiotherapy for locally advanced anal cancer (European Organisation for Research and Treatment of Cancer phase II study 22011-40014). Eur J Cancer. 2009 Nov;45(16):2782-91. doi: 10.1016/j.ejca.2009.06.020. Epub 2009 Jul 28. PMID 19643599