Adaptive Radiation in Anal Cancer

Description

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.

Conditions

Anal Squamous Cell Carcinoma

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Study Overview

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Study Details

Study overview

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.

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

Adaptive Radiation in Anal Cancer

Condition
Anal Squamous Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Lisa Kachnic, MD, PRINCIPAL_INVESTIGATOR, Principal Investigator

Study Record Dates

2028-12-31