RECRUITING

Pre-operative Hypofractionated Proton Therapy

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 study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures. Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.

Official Title

PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma

Quick Facts

Study Start:2024-04-18
Study Completion:2032-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05917301

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. * Adult patients (≥18 years of age)
  2. * Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
  3. * WHO/ECOG status ≤2
  1. * History of prior local radiation therapy
  2. * Inability to tolerate treatment position for duration of simulation or treatment
  3. * Tumor originating in retroperitoneal location
  4. * Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy
  5. * Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators.
  6. * Confirmed pregnancy.

Contacts and Locations

Study Contact

Curtiland Deville, MD
CONTACT
202-537-4788
cdeville@jhmi.edu
Ryan Manuel
CONTACT
rmanuel5@jhmi.edu

Principal Investigator

Curtland Deville, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine

Study Locations (Sites)

Sibley Memorial Hospital
Washington, District of Columbia, 20016
United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Curtland Deville, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

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 Date2024-04-18
Study Completion Date2032-12

Study Record Updates

Study Start Date2024-04-18
Study Completion Date2032-12

Terms related to this study

Keywords Provided by Researchers

  • proton therapy
  • soft tissue sarcoma
  • hypofractionated

Additional Relevant MeSH Terms

  • Soft Tissue Sarcoma