NCT06050707

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
28mo left

Started Sep 2023

Longer than P75 for phase_2

Geographic Reach
3 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Sep 2023Sep 2028

First Submitted

Initial submission to the registry

August 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

August 18, 2023

Last Update Submit

March 5, 2026

Conditions

Anal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Change in locoregional failure (LRF) at Year 2

    Any local or regional failure from the date of registration to the date of any of the local or regional failure.

    2 years

Secondary Outcomes (8)

  • Presence of distant metastasis (DM)

    5 years

  • Colostomy rate

    5 years

  • Disease free survival (DFS)

    5 years

  • Overall survival (OS)

    5 years

  • Physician-reported toxicities

    5 years

  • +3 more secondary outcomes

Interventions

Radiotherapy - Low risk groupRADIATION

20 fractions completed in 4 weeks

Radiotherapy - Standard risk groupRADIATION

25 fractions completed in 5 weeks

Radiotherapy - Intermediate risk groupRADIATION

30 fractions completed in 6 weeks

Radiotherapy - High risk groupRADIATION

35 fractions completed in 7 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

NOT YET RECRUITING

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

NOT YET RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Central Study Contacts

Ali Hosni

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 22, 2023

Study Start

September 29, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)CA(1)US(2)