RECRUITING

Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

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

The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.

Official Title

Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Quick Facts

Study Start:2021-03-02
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04506008

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. * Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
  2. * ECOG performance status 0-2
  3. * Patient must be deemed able to comply with radiation treatment and surgery
  1. * History of prior radiation to the same area to be irradiated
  2. * Pregnancy
  3. * Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects

Contacts and Locations

Study Contact

Vanderbilt-Ingram Service for Timely Access
CONTACT
800-811-8480
cip@vumc.org

Principal Investigator

Eric Shinohara, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt Medical Center

Study Locations (Sites)

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt-Ingram Cancer Center

  • Eric Shinohara, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt Medical Center

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 Date2021-03-02
Study Completion Date2027-06

Study Record Updates

Study Start Date2021-03-02
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Hypofractionated Radiotherapy

Additional Relevant MeSH Terms

  • Soft Tissue Sarcomas