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New treatment option for Anal Canal Cancer
Official title Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer
ClinicalTrials.gov ID: NCT05040815
What this study is testing
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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).
- 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 menarche and who has not undergone surgical...
- Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is...
- Females must not breastfeed during study treatment.
- Male patients should agree to not donate sperm during study treatment.
- Absence of any condition hampering compliance with study protocols and follow-up schedule; those conditions should be reviewed with the patient prior to trial registration.
- 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.
- Comorbid medical conditions precluding radical treatment at the discretion of Oncologist.
- Histology other than squamous cell carcinoma or variants.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.