Recruiting
Phase 2

Radiotherapy

Sponsor:

AHS Cancer Control Alberta

Code:

NCT05040815

Conditions

Anal Canal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

chemo-radiation treatment

Study Details

Brief 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

Conditions

Anal Canal Cancer

Study ID

NCT05040815

Start date

May 11, 2023

Status verified date

Oct, 2025

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: chemo-radiation treatment

Radiotherapy with concurrent 5-fluorouracil and mitomycin-C combination treatment.

Radiotherapy consists of 5400 cGy delivered in 30 fractions over 6 weeks. The investigators will be using the current standard regimen for the study or no change in the current CCI treatment regimen. However, the radiotherapy target will be smaller than current practice since the investigators will be omitting prophylactic inguinal irradiation.

Interventions

chemo-radiation treatment

Radiotherapy (RT) with concurrent 5-fluorouracil and mitomycin-C (5FU/MMC) combination is the treatment of choice for non-metastatic locally advanced anal squam

Primary outcome measure

  • Incidence of inguinal lymph node recurrence [ Time Frame: Total duration of follow up is 36 months ]
  • Disease free survival (DFS) [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Locations

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

More Information

Sponsor

AHS Cancer Control Alberta

Last update posted

Oct 2, 2025

Last verified

Oct, 2025

Keywords

  • radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AHS Cancer Control Alberta on 2025-10-02.