Health TrialsbyHealthPanel

Adaptive Radiation in Anal Cancer

ConditionAnal Squamous Cell Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery

    Radiation

    Subjects will receive 54 Gy of radiation delivered 5 day a week for 6 weeks, 30 radiation treatments total. Intensity-Modulated photon radiation therapy will be delivered on a Varian Ethos linear accelerator. Daily image-guided radiation therapy (IGRT) is required. All treatments will have artificial-intelligence (AI) daily adaptations of the radiation plan to optimize the radiation dose to the targeted area and minimize radiation dose to the normal surrounding organs such as the bowel.

  • Mitomycin-C

    Drug

    As part of the subjects' treatment, 10 mg/meters squared of Mitomycin C will be administered intravenously (IV-into the vein) on Day 1 and Day 29.

  • 5-Fluorouracil

    Drug

    As part of the subjects' treatment, 1g/meters squared/day for 4 days of 5-Fluorouracil will be administered by continuous infusion on Days 1-4 (for 96 hours) and Days 29-32 (for 96 hours). 5-Fluorouracil or capecitabine will be administered per the physician's discretion.

  • Capecitabine

    Drug

    As part of the subjects' treatment, 825 mg/meters squared per day, divided into 2 daily doses, will be taken on days of radiotherapy. Capecitabine or 5-FU will be administered per the physician's discretion.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Chemotherapy and Adaptive Radiation Treatment PlanningExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Time to plan and deliver treatment fractions.

This is defined by the time the first cone beam computed tomography to the end of treatment delivery for each treatment.

Time frame
Up to 6 weeks

Secondary outcomes

1

Acute Treatment Toxicity

Toxicity of treatment will be analyzed using NCI-CTCAE v5.0.

Time frame
Up to 1 month post-treatment
2

Complete Clinical Response Rate

Complete response to treatment (CR) is defined as absence of detectable cancer.

Time frame
6 months following the completion of chemoradiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Varian Medical Systems

Collaborator

Source ClinicalTrials.gov
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