About this trial
This is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer. The tumor and a patient's anatomy may change during radiation treatment and daily adaption of the radiation plan (i.e., a new daily plan based on the anatomy of the day) may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs.
Eligibility criteria
Qualifiers
Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal.
American Joint Committee on Cancer (AJCC) 8th edition stage T2 > 4 cm, T3-4 or N1.
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
Disqualifiers
Prior or co-existing invasive malignancy (except non-melanomatous skin cancer) unless disease free ≥ 2 years.
Prior chemotherapy or radiation for anal cancer.
Patients who have undergone complete surgical resection.
Presence of recurrent/metastatic disease.
Trial design
Treatments tested in this trial
- Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery
- Mitomycin-C
- 5-Fluorouracil
- Capecitabine
Treatment groups
Sponsors and collaborators
Columbia University
Lead sponsor
Varian Medical Systems
Collaborator