Adaptive Radiation in Anal Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

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

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Columbia University

Lead sponsor

Varian Medical Systems

Collaborator