Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer
The purpose of this study is to see whether avoiding preventative radiation to the groin in patients with normal sentinel node biopsy and PET-CT, is at least as effective treating cancer as giving preventative radiation to the groin for patients with anal canal cancer. The investigators also want to know if avoiding ra
| Condition(s) | Anal Canal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to see whether avoiding preventative radiation to the groin in patients with normal sentinel node biopsy and PET-CT, is at least as effective treating cancer as giving preventative radiation to the groin for patients with anal canal cancer. The investigators also want to know if avoiding radiation to the groin will cause fewer side effects and better quality of life |
| Who can participate | Inclusion Criteria: 1. Participants capable of giving informed consent. 2. Patients must be 18 years of age or older. 3. Patient should have histologically proven primary squamous cell carcinoma. 4. Patients must have early AC, Stage T1-3 N0 M0. 5. No inguinal nodal involvement confirmed by PET imaging and SLNB. 6. No history of prior malignancy other than non-melanoma skin cancer or other malignancy with disease free survival ≥ 5 years. 7. Performance status ECOG 0-2 / Zubrod performance status ≥70. 8. Patient should be eligible for concomitant chemotherapy (e.g. adequate hepatic, renal and bone marrow function). 9. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced mena |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | AHS Cancer Control Alberta |
| Locations | Edmonton, Alberta, Canada |
| Start date | 2023-05-11 |
| NCT ID | NCT05040815 |
| Official listing | https://clinicaltrials.gov/study/NCT05040815 |