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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University Health Network, Toronto
Study ID
NCT06050707
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy - Low risk group — RADIATION
    20 fractions completed in 4 weeks
  • Radiotherapy - Standard risk group — RADIATION
    25 fractions completed in 5 weeks
  • Radiotherapy - Intermediate risk group — RADIATION
    30 fractions completed in 6 weeks
  • Radiotherapy - High risk group — RADIATION
    35 fractions completed in 7 weeks

Study Details

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.

Key Dates

Start date
Sep 29, 2023
Status verified
Jun 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Allegheny Health NetworkPittsburghPennsylvania15212
Alexander Kirichenko, MD
Medical College of Wisconsin Cancer CenterMilwaukeeWisconsin53226
William A Hall, MD

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