At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma of the anal canal, previously untreated
- ✓AJCC stage II-IIIB disease (T1-4, NX, M0)
- ✓Age ≥16 years old
- ✓ECOG performance status 0-1
- ✕Prior chemotherapy with oxaliplatin, capecitabine, or 5-fluorouracil
- ✕Prior pelvic radiation therapy
- ✕Prior surgery for anal cancer (excluding biopsy)
- ✕Known dihydropyrimidine (DPD) deficiency
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT), XELOX/RT in Squamous Cell Carcinoma of the Anal Canal
In Brief
A Phase 2 clinical trial evaluating Capecitabine, Oxaliplatin, and 1 other intervention for Anal Cancer. Completed, enrolled 20 participants across 1 site.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer.
Study Details
Timeline
Interventions
825 mg/m\^2 orally twice a day (BID), Mon-Fri during weeks 1, 2, 4, and 5.
50 mg/m\^2 by vein (IV) over 2 hours on days 1, 8, 22, and 29.
Undergo radiotherapy\* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. \*Patients with T3-4 lesions undergo radiotherapy once daily on days 43 and 44.