IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer

The standard practice in management of carcinoma of anal canal is to treat patients with radiotherapy using the IMRT technique along with chemotherapy. It is known that while IMRT has reduced treatment related side effects as compared to the older radiation techniques, reducing these side effects further still remains a major challenge. These side-effects include gastrointestinal (diarrhea, altered bowel habits, weight loss, bleeding, obstruction), genitourinary (difficulties in passing urine, passing blood in urine, difficulty in holding urine) and hematologic toxicities (anemia, low platelet count and increased predisposition to infections). Proton therapy (IMPT) is a form of radiation treatment in which high doses can be delivered within the tumor while the surrounding normal tissues receive a lesser radiation dose. It is believed that these physical properties of proton therapy may help reduce the side effects of treatment. Patients will be randomly assigned to either receive IMRT or IMPT based treatment so as to see whether it is possible to reduce the acute treatment related toxicities. In this study, there is a 66.7% chance that the patient will get IMPT based treatment, which may be able to reduce the toxicities.

NCT Number	NCT06630793
Lead Sponsor	Tata Memorial Centre
Conditions	Malignant Neoplasm of Anal Canal
Enrollment	108 participants
Start Date	2025-03-18
Primary Completion	2027-11-01 (estimated)
Study Completion	2032-05-01 (estimated)
Updated on ClinicalTrials.gov	2025-04-08