Phase III Randomised Control Trial ofIntensity-Modulated Radiotherapy usingPhoton Versus Proton with ConcurrentChemotherapy for Locally Advanced AnalCanal Cancer - IMPAC

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1. Age more than 18 and less than 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 to 2 with N positive, M0 or T3 to 4, N0 to 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 to 1
•6. With suitable blood test values for standard concurrent chemotherapy (Hb more than 10 mg/dL, ANC more than 1.5 cells/mm3, Platelets more than 100,000 cells/mm3 Creatinine less than 1.5 x ULN, Bilirubin less than 3 x ULN, ALT less than 3 x ULN) as deemed by a medical oncologist in team.
•7. The patient must be expected to tolerate the treatment and be compliant for follow up.
•8. No contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc.
•9. Willing to consent to participate in the study.

•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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