This phase 2 single-arm study will evaluate whether a shortened course of mildly hypofractionated radiation therapy given with standard concurrent chemotherapy (mitomycin C and capecitabine) can provide acceptable tumor control in patients with high-risk non-metastatic anal squamous cell carcinoma. Standard chemoradiation for anal cancer typically requires approximately 5.5 to 6 weeks of daily radiation, which can create substantial logistical burden for patients and caregivers, particularly those in rural settings.
The investigational approach uses a 23-fraction radiation regimen designed to shorten treatment duration while maintaining biologically equivalent tumor-directed dosing compared with standard treatment. The primary question is whether this shorter chemoradiation regimen can achieve an acceptable 6-month complete clinical response rate while maintaining manageable toxicity.
Age 18 years or older
Patients with HPV-associated (p16-positive) perianal cancer are eligible if the tumor extends to the anal verge
Karnofsky Performance Status >60
Creatinine clearance >30 mL/min
Prior pelvic radiation therapy
Uncontrolled intercurrent illness that, in the opinion of the investigator, would prevent safe receipt of radiation therapy or capecitabine
Prior or concurrent malignancy that, in the opinion of the investigator, could interfere with assessment of safety or efficacy
Current receipt of another investigational agent for treatment of anal squamous cell carcinoma