Adaptive Radiation in Anal Cancer

July 12, 2023 updated by: Lisa A. Kachnic, Columbia University

Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The standard treatment for Human Papilloma Virus (HPV)-positive locally advanced anal cancer (described as a tumor that is greater than 4 cm in size, or with positive lymph nodes) is 54 Gy of radiation treatment to the anal canal and primary tumor planning total volume (PTV), 50.4-54 Gy to positive nodal PTV and 45 Gy to elective lymph node PTV with 5-fluorouracil (5-FU) and mitomycin-C chemotherapy administered at the same time as radiation in 30 fraction (treatments) delivery. During the six week course of radiotherapy, there is often a notable decrease in volume of the tumor (both primary and regional nodes), as early as one week into treatment, detected on weekly on-board Cone Beam Computed Tomography (CBCT), which is a scan done on the treatment machine while patients receive radiation to ensure that the tumor is being treated and normal tissue is not. However, CT simulation (a CT scan used to plan radiation treatment) and re-planning of the treatment to account for the tumor shrinkage are not routinely performed due to time, patient inconvenience and staffing resources. As such, daily adaptive radiation, which can generate a new CT-based plan using the anatomy of the day, may be a time efficient method to both plan and treat the patient.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Lisa Kachnic, MD
        • Sub-Investigator:
          • David Horowitz, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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%).
  • Life expectancy of greater than 12 months.
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes greater than or equal to 3,000/microliter
  • absolute neutrophil count greater than or equal to 1,500/microliter
  • platelets greater than or equal to 100,000/microliter
  • total bilirubin within normal institutional limits
  • Aspartate transaminase (AST)(SGOT)/Alanine transaminase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal
  • creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • Females of childbearing potential and males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of study therapy. All pregnancies must be reported.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • 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.
  • Prior allergic reaction to 5-Fluorouracil or mitomycin C.
  • Artificial organ prosthetics, pacemakers or other implantable devices.
  • Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields.
  • Uncontrolled inter-current illness including but not limited to known history of HIV with cluster of differentiation 4 (CD4) count less than 200 or symptomatic cardiac disease.
  • Women who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemotherapy and Adaptive Radiation Treatment Planning
Subjects will receive concurrent chemotherapy and radiation as part of their treatment for anal cancer. Subjects will receive standard of care 54 Gy of radiation, 5 days a week for 6 weeks. In addition, subjects will receive standard of care chemotherapy, with mitomycin C (10mg/meters squared IV on Day 1) and 5-Fluorouracil (1000mg/meters squared via IV on days 1-4 and 29-32) or capecitabine (825 mg/meters squared in two divided doses by mouth on days of radiotherapy).
Radiation: Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery
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.
Other Names:
  • Adaptive RT Planning and Delivery
Drug: Mitomycin-C
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.
Drug: 5-Fluorouracil
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.
Other Names:
  • 5-FU
Drug: Capecitabine
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.
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to plan and deliver treatment fractions.
Time Frame: Up to 6 weeks
This is defined by the time the first cone beam computed tomography to the end of treatment delivery for each treatment.
Up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Treatment Toxicity
Time Frame: Up to 1 month post-treatment
Toxicity of treatment will be analyzed using NCI-CTCAE v5.0.
Up to 1 month post-treatment
Complete Clinical Response Rate
Time Frame: 6 months following the completion of chemoradiation
Complete response to treatment (CR) is defined as absence of detectable cancer.
6 months following the completion of chemoradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Varian Medical Systems

Investigators

  • Principal Investigator: Lisa Kachnic, MD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU0074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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