RECRUITING

Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas

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Conditions

Soft Tissue Sarcomahypofractionatedradiotherapy

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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 research study is designed to find out if radiation therapy treatment prior to surgery is safe and effective to treat soft tissue sarcomas. 30 participants with soft tissue sarcoma will be enrolled and can expect to be on study for up to 5 years.

Official Title

Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Versus Conventionally Fractionated Radiotherapy for Soft Tissue Sarcomas

Quick Facts

Study Start:2022-04-06
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05109494

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. * Biopsy proven soft tissue sarcoma of the extremity, trunk, or head and neck
  2. * No prior sarcoma-directed chemotherapy or radiotherapy
  3. * Age ≥ 18 years
  4. * Karnofsky performance status ≥ 60
  5. * Able to understand and sign an informed consent
  6. * Life expectancy of greater than 12 weeks
  7. * Hypofractionated or conventionally fractionated radiotherapy using Intensity Modulated Radiation Therapy (IMRT) are both deemed feasible and safe neoadjuvant treatments, at the treating physician's discretion
  8. * Operable disease and medically fit for surgery, based on the opinion of the consulting surgeon; surgery within 5-14 days of completion of radiation therapy (RT)
  9. * Adequate bone marrow function as defined by absolute neutrophil count \> 500/mcL, hemoglobin \> 8 g/dL, platelets \> 50,000/mcL; adequate renal function as defined by creatinine clearance \> 30 mL/min
  1. * Pregnant
  2. * Unable to undergo imaging or positioning necessary for radiotherapy planning

Contacts and Locations

Study Contact

Cancer Connect
CONTACT
800-622-8922
clinicaltrials@cancer.wisc.edu

Principal Investigator

Zachary Morris, MD, PhD
PRINCIPAL_INVESTIGATOR
UW School of Medicine and Public Health

Study Locations (Sites)

University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Zachary Morris, MD, PhD, PRINCIPAL_INVESTIGATOR, UW School of Medicine and Public Health

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 Date2022-04-06
Study Completion Date2026-11

Study Record Updates

Study Start Date2022-04-06
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • hypofractionated
  • radiotherapy

Additional Relevant MeSH Terms

  • Soft Tissue Sarcoma