Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT06630793
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06630793
Study Brief:
Protocol Section:
NCT06630793