MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 years
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients will be followed for up to 5 years after radiotherapy and be required to complete questionnaires and clinic visits."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests radiation treatment guided by MRI scans for adults with anal cancer. The radiation dose is based on each person's cancer risk group. Researchers will also study DNA from human papillomavirus (HPV) to look for clues about how well treatment works and what side effects it causes.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- A tissue test shows anal squamous cell cancer, including certain related types or cancer at the outer edge of the anus.
- Your cancer is stage T1–4, N0–1, M0. It may involve nearby lymph nodes but has not spread to distant parts of the body.
- You can receive radiation, alone or with chemotherapy, as treatment meant to cure the cancer.
- You can care for yourself and are up and about for at least half of your waking hours.
Who can't join
- You have already had chemotherapy, radiation, or surgery meant to cure your anal cancer.
- You had radiation to your belly or pelvis that would overlap with the area treated in this study.
- You had another cancer, unless you have been cancer-free for at least 2 years and the study doctor thinks it is unlikely to return. Exceptions include treated early cervical cancer that has not spread and treated basal cell or squamous cell skin cancer diagnosed within the past 5 years.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (2)
PA
- Allegheny Health Network · Pittsburgh, PA 15212Alexander Kirichenko, MD · Study contactMore trials in Pittsburgh
WI
- Medical College of Wisconsin Cancer Center · Milwaukee, WI 53226William A Hall, MD · Study contactMore trials in Milwaukee