Radiotherapy using Photon versus Proton technique with Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer

Phase 3

• Conditions: Health Condition 1: C211- Malignant neoplasm of anal canal

• Registration Number: CTRI/2024/05/066687
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of grade 2 or higher acute GI/GU/haematological toxicityTimepoint: Upto 6 months post-last cytotoxic therapy.