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

RecruitingNAAges 18 Years - 80 YearsAllTata Memorial Centre
NCT06630793 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age \> 18 and \< 80 years of age 2. Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum 3. The patients may have TNM stage T1-2 N+M0 or T3-4 N0-1c M0 (UICC 8th edition) 4. Involvement of lower para-aortic lymph nodes (till renal hilum) as the only site of disease extension on PET CECT may also be included as they receive radical chemoradiation as standard treatment. 5. WHO or ECOG performance status 0-1 6. HIV testing is known and HPV (P16) testing done on tissue sample. 7. With suitable blood test values for standard concurrent chemotherapy (Hb \> 10 mg/dL, ANC \> 1.5 cells/mm3, Platelets \> 100,000 cells/mm3, Creatinine \< 1.5 x ULN, Bilirubin \< 3 x ULN, ALT \< 3 x ULN) as deemed by a medical oncologist in team. 8. The patient must be expected to tolerate the treatment and be compliant for follow up. 9. No contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc. 10. Willing to consent to participate in the study. Exclusion Criteria: 1. Two or more synchronous primary cancers. 2. When prosthetic materials (e.g. hip prostheses) are present close to the target volume, it must be considered if this may introduce uncertainties in dose calculations, which may affect the treatment planning process. 3. Ulcerative colitis or any other histologically confirmed inflammatory bowel disease. 4. Poor reliability for follow-up and treatment completion.
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What it tests

  • IMPT (Intensity Modulated Proton Therapy)
  • IMRT (Intensity Modulated Radiation Therapy)
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Where

1 site
Tata Memorial Centre
Mumbai, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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