MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy - Low risk group, Radiotherapy - Standard risk group, Radiotherapy - Intermediate risk group, Radiotherapy - High risk group.
- Who it may be relevant to
- Registry conditions: Anal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a risk-stratified dose of treatment (radiation dose and chemotherapy number of cycles) based on predefined clinical and biological biomarkers for anal squamous cell carcinoma (SCC). Radiotherapy will be delivered on the MR-Linac for image-guided-radiation therapy (IGRT). Patients will be followed for up to 5 years after radiotherapy and be required to complete questionnaires and clinic visits. Patients have the option to complete blood and tissue samples during the study.
Interventions
- Radiation Radiotherapy - Low risk group
20 fractions completed in 4 weeks - Radiation Radiotherapy - Standard risk group
25 fractions completed in 5 weeks - Radiation Radiotherapy - Intermediate risk group
30 fractions completed in 6 weeks - Radiation Radiotherapy - High risk group
35 fractions completed in 7 weeks
Primary outcome measures
- Change in locoregional failure (LRF) at Year 2 [Time frame: 2 years]
Secondary outcome measures (8)
- Presence of distant metastasis (DM) [Time frame: 5 years]
- Colostomy rate [Time frame: 5 years]
- Disease free survival (DFS) [Time frame: 5 years]
- Overall survival (OS) [Time frame: 5 years]
- Physician-reported toxicities [Time frame: 5 years]
- Patient Reported Outcomes [Time frame: 5 years]
- Quality of life (QOL) [Time frame: 5 years]
- Quality of life (QOL) [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Allegheny Health Network — Pittsburgh
- Medical College of Wisconsin Cancer Center — Milwaukee
Canada · 2 centers
- Princess Margaret Cancer Centre — Toronto
- CHUM - Centre hospitalier de l'Université de Montréal — Montreal
Australia · 1 center
- Austin Health — Heidelberg
Identifiers
NCT: NCT06050707 · 23-5323