RECRUITING

MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

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Conditions

Anal Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

Quick Facts

Study Start:2023-09-29
Study Completion:2028-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06050707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Clinical stage T1-4 N0-1 M0 (the Union for International Cancer Control (UICC) / the American Joint Committee on Cancer (AJCC) 8th Ed)
  3. * Patients must be eligible for definitive RT or CRT
  4. * Must be ≥ 18 years of age
  5. * Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  1. * Previous chemotherapy, RT or curative-intent surgical treatment (i.e. APR) for anal cancer.
  2. * Any previous RT to the abdomino-pelvic region that would result in overlap of RT volume for the current study.
  3. * 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.

Contacts and Locations

Study Contact

Ali Hosni
CONTACT
416-946-2360
ali.hosni@uhn.ca

Study Locations (Sites)

Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: University Health Network, Toronto

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29
Study Completion Date2028-09-01

Study Record Updates

Study Start Date2023-09-29
Study Completion Date2028-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Anal Squamous Cell Carcinoma