Recruiting
Phase 2

MR-guided RT

Sponsor:

University Health Network, Toronto

Code:

NCT06050707

Conditions

Anal Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiotherapy - Low risk group

Radiotherapy - Standard risk group

Radiotherapy - Intermediate risk group

Radiotherapy - High risk group

Study Details

Brief summary:

The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.

Conditions

Anal Squamous Cell Carcinoma

Study ID

NCT06050707

Start date

Sep 29, 2023

Status verified date

Jun, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with pathologically proven diagnosis of anal SCC. This may include tumors of non-keratinizing histology such as basoloid or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible.
  • Clinical stage T1-4 N0-1 M0 (the Union for International Cancer Control (UICC) / the American Joint Committee on Cancer (AJCC) 8th Ed)
  • Patients must be eligible for definitive RT or CRT
  • Must be ≥ 18 years of age
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

  • Previous chemotherapy, RT or curative-intent surgical treatment (i.e. APR) for anal cancer.
  • Any previous RT to the abdomino-pelvic region that would result in overlap of RT volume for the current study.
  • Individuals with a history of a different malignancy except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Radiotherapy - Low risk group

20 fractions completed in 4 weeks

Radiotherapy - Standard risk group

25 fractions completed in 5 weeks

Radiotherapy - Intermediate risk group

30 fractions completed in 6 weeks

Radiotherapy - High risk group

35 fractions completed in 7 weeks

Primary outcome measure

  • Change in locoregional failure (LRF) at Year 2 [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Ali Hosni

416-946-2360ali.hosni@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C1

Contacts

Ali Hosni, MD

416-946-2360ali.hosni.abdalaty@rmp.uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-10.