Anal cancer patients may avoid groin radiation side effects
NCT ID NCT05040815
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with early-stage anal cancer. It tests whether skipping radiation to the groin (when scans and biopsies show no cancer there) works just as well as giving it, while causing fewer side effects and better quality of life. About 45 participants will receive standard treatment but without groin radiation, and be followed for up to 3 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \> 40 mIU/mL to confirm menopause. 10. 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 defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly (Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard). 11. Females must not breastfeed during study treatment. 12. Male patients should agree to not donate sperm during study treatment. 13. 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. Exclusion Criteria: 1. T1N0 patients going for primary surgery 2. Prior radiation therapy to the pelvis. 3. Pregnancy or lactation. 4. Prior surgical treatment for anal cancer other than biopsy. 5. Prior surgical or chemotherapy treatment for anal cancer. 6. Evidence of distant metastases. 7. Comorbid medical conditions precluding radical treatment at the discretion of Oncologist. 8. Histology other than squamous cell carcinoma or variants.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cross Cancer Institute
RECRUITINGEdmonton, Alberta, T6G 1Z2, Canada
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