Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer (NCT05040815) | Clinical Trial Compass
RecruitingPhase 2
Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer
Canada45 participantsStarted 2023-05-11
Plain-language 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
Age range18 Years
SexALL
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Inclusion criteria
✓. Participants capable of giving informed consent.
✓. Patients must be 18 years of age or older.
✓. Patient should have histologically proven primary squamous cell carcinoma.
✓. Patients must have early AC, Stage T1-3 N0 M0.
✓. No inguinal nodal involvement confirmed by PET imaging and SLNB.
✓. No history of prior malignancy other than non-melanoma skin cancer or other malignancy with disease free survival ≥ 5 years.
✓. Performance status ECOG 0-2 / Zubrod performance status ≥70.
✓. Patient should be eligible for concomitant chemotherapy (e.g. adequate hepatic, renal and bone marrow function).
Exclusion criteria
✕. T1N0 patients going for primary surgery
✕. Prior radiation therapy to the pelvis.
✕. Pregnancy or lactation.
✕. Prior surgical treatment for anal cancer other than biopsy.
✕. Prior surgical or chemotherapy treatment for anal cancer.
✕. Evidence of distant metastases.
What they're measuring
1
Incidence of inguinal lymph node recurrence
Timeframe: Total duration of follow up is 36 months