RECRUITING

Adaptive Radiation in Anal Cancer

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Conditions

Anal Squamous Cell CarcinomaAnal cancerAdaptive radiationChemotherapyRadiotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-05-18
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05838391

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal.
  2. * American Joint Committee on Cancer (AJCC) 8th edition stage T2 \> 4 cm, T3-4 or N1.
  3. * Age ≥18 years.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).
  5. * Life expectancy of greater than 12 months.
  6. * Patients must have normal organ and marrow function as defined below:
  7. * leukocytes greater than or equal to 3,000/microliter
  8. * absolute neutrophil count greater than or equal to 1,500/microliter
  9. * platelets greater than or equal to 100,000/microliter
  10. * total bilirubin within normal institutional limits
  11. * Aspartate transaminase (AST)(SGOT)/Alanine transaminase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal
  12. * creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  13. * 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.
  14. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Prior or co-existing invasive malignancy (except non-melanomatous skin cancer) unless disease free ≥ 2 years.
  2. * Prior chemotherapy or radiation for anal cancer.
  3. * Patients who have undergone complete surgical resection.
  4. * Presence of recurrent/metastatic disease.
  5. * Prior allergic reaction to 5-Fluorouracil or mitomycin C.
  6. * Artificial organ prosthetics, pacemakers or other implantable devices.
  7. * Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields.
  8. * 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.
  9. * Women who are pregnant or lactating.

Contacts and Locations

Study Contact

Mariamne Reyna
CONTACT
646-317-4244
mo2213@cumc.columbia.edu

Principal Investigator

Lisa Kachnic, MD
PRINCIPAL_INVESTIGATOR
Principal Investigator

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Columbia University

  • Lisa Kachnic, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-05-18
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-05-18
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Anal cancer
  • Adaptive radiation
  • Chemotherapy
  • Radiotherapy

Additional Relevant MeSH Terms

  • Anal Squamous Cell Carcinoma