Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer
Intensification Therapy for Locally Advanced Epidermoid Cancer of the Anal Canal - Phase III Intergroup Study
- 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. 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.
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 |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 colostomyReferences
Publications (1)
- RESULTTournier-Rangeard L, Mercier M, Peiffert D, Gerard JP, Romestaing P, Lemanski C, Mirabel X, Pommier P, Denis B. Radiochemotherapy of locally advanced anal canal carcinoma: prospective assessment of early impact on the quality of life (randomized trial ACCORD 03). Radiother Oncol. 2008 Jun;87(3):391-7. doi: 10.1016/j.radonc.2007.12.004. Epub 2008 Jan 11. PMID 18191265