Actively Recruiting
IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
Led by Tata Memorial Centre · Updated on 2025-04-08
108
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 and less than 80 years
- Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum
- TNM stage T1-2 N+ M0 or T3-4 N0-1c M0 (UICC 8th edition)
- Involvement of lower para-aortic lymph nodes up to the renal hilum as the only site of disease extension
- Performance status of 0 or 1 on WHO or ECOG scale
- Known HIV testing status and HPV (P16) testing on tissue sample
- Suitable blood test results for standard chemotherapy as determined by a medical oncologist
- Expected ability to tolerate treatment and comply with follow-up
- No contraindications for chemoradiation such as inflammatory bowel disease or pregnancy
- Willingness to provide informed consent to participate in the study
You will not qualify if you...
- Presence of two or more synchronous primary cancers
- Presence of prosthetic materials near the treatment area that may affect radiation dosing
- Diagnosis of ulcerative colitis or other histologically confirmed inflammatory bowel diseases
- Unreliable for follow-up visits and treatment completion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
D
Dr Rahul Krishanatry, MD
CONTACT
D
Dr Rahul Krishanatry, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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