Health Condition 1: C211- Malignant neoplasm of anal canal
Conditions
Interventions
Intervention1: 1.Intensity modulated Radiotherapy
2.Intensity modulated Proton beam therapy: 1. The standard practice in management of carcinoma of anal canal is to treat patients
with radiotherapy us
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 2 or higher acute GI/GU/haematological toxicityTimepoint: Upto 6 months post-last cytotoxic therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Late toxicities: After 3 months of treatment and up to 5 years or death due to any cause, will be documented using CTCAE v5.0Timepoint: 5 years;To estimate and compare Health Related Quality Of Life (EORTC QLQ-C30, QLQ PRT20, QLQ ANL27, QLQ SH22), LARS, IPSS score, EQ 5D-5L-VAS, QLU C10D between IMPT and IMRT arms.Timepoint: 5 years;To estimate the colostomy-free survival rates and if any difference between the IMPT and IMRT armsTimepoint: 5 years;To estimate the disease-free survival rates and if any difference between the IMPT and IMRT arms.Timepoint: 5 years;To estimate the distant relapse rates and if any difference between the IMPT and IMRT armsTimepoint: 5 years;To estimate the local failure rates and if any difference between the IMPT and IMRT armsTimepoint: 5 years ;To estimate the locoregional failure rates and if any difference between the IMPT and IMRT armsTimepoint: 5 years;To estimate the overall survival rates and if any difference between the IMPT and IMRT armsTimepoint: 5 years;To estimate the regional failure rates and if any difference between the IMPT and IMRT armsTimepoint: 5 years | — |
Countries
India
Contacts
Public ContactDr Rahul Krishnatry
Tata Memorial Centre
Outcome results
None listed