Actively Recruiting
Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer
Led by AHS Cancer Control Alberta · Updated on 2025-10-02
45
Participants Needed
1
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants capable of giving informed consent
- Age 18 years or older
- Histologically confirmed primary squamous cell carcinoma
- Early anal cancer, Stage T1-3 N0 M0
- No inguinal nodal involvement confirmed by PET imaging and sentinel lymph node biopsy
- No history of prior malignancy except non-melanoma skin cancer or other malignancy with disease-free survival of 5 years or more
- ECOG performance status 0-2 or Zubrod performance status ≤70
- Eligible for concurrent chemotherapy with adequate liver, kidney, and bone marrow function
- Women of childbearing potential must have a negative pregnancy test at screening
- Women of childbearing potential defined as females who have had menarche and are not surgically sterilized or postmenopausal (menopause defined by 12 months amenorrhea over age 45 or FSH > 40 mIU/mL for females under 55)
- Patients of reproductive potential must use highly effective birth control during treatment
- Females must not breastfeed during treatment
- Male patients must agree not to donate sperm during treatment
- No conditions preventing compliance with study protocols and follow-up
You will not qualify if you...
- T1N0 patients planned 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
- Medical conditions that prevent radical treatment as judged by the oncologist
- Histology other than squamous cell carcinoma or its variants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
Research Team
K
Kurian Joseph, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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