Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall

NCT02634710 | Completed Results DMC FDA Device

• 1 other identifier: 25722
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and disease control (local control, overall and progression-free survival) using hypofractionated preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).

Conditions

Soft Tissue Sarcoma

Keywords

soft tissue sarcoma

Outcome Measures

Primary Outcomes (2)

• Local Disease Control Assessed by Physical Examination

  This measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.

  2 Years

• Local Disease Control Assessed by Magnetic Resonance Imaging (MRI)

  This measure is the number of subjects experiencing a recurrence of the primary lesion as assessed by MRI.

  2 years

Secondary Outcomes (6)

• Musculoskeletal Tumor Rating Scale (MSTS) Score

  Baseline, prior to surgery and 24 months after surgery

• Disease-free Survival

  2 Years

• Overall Survival

  2 Years

• Radiologic Changes Due to Hypofractionated Radiation.

  4 weeks after radiation therapy

• Pathologic Changes Due to Hypofractionated Radiation.

  2 weeks after surgery

Study Arms (1)

Hypofractionated Radiation Therapy

EXPERIMENTAL

Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.

Hypofractionated Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age
• Core needle biopsy obtained
• Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall.
• Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease
• Medically operable
• No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
• MRI obtained of the affected extremity or chest-wall
• CT chest acquired to assess distant disease
• Karnofsky Performance Status (KPS) 60 or above
• Informed consent obtained prior to study entry

You may not qualify if:

• Patients who have metastatic disease
• Pregnant women
• Women of childbearing potential and male participants must practice adequate contraception.
• Disease pathology other than sarcoma subtypes
• Patients with a history of metastatic disease from a primary other than sarcoma
• Patients who cannot undergo MRI as part of pre-treatment or treatment planning process
• STS of non-extremity or chest-wall regions
• Tumor size ≥ 20 cm maximal dimension

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Bedi M, Singh R, Charlson JA, Kelly T, Johnstone C, Wooldridge A, Hackbarth DA, Moore N, Neilson JC, King DM. Is 5 the New 25? Long-Term Oncologic Outcomes From a Phase II, Prospective, 5-Fraction Preoperative Radiation Therapy Trial in Patients With Localized Soft Tissue Sarcoma. Adv Radiat Oncol. 2022 Jan 25;7(3):100850. doi: 10.1016/j.adro.2021.100850. eCollection 2022 May-Jun.

  PMID: 35647402 RESULT

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Ciani Ellison, MD
• Organization: Froedtert and the Medical college of Wisconsin

cellison@mcw.edu

414-805-4400

Study Officials

• Ciani Ellison, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: December 18, 2015
• Study Start: February 23, 2016
• Primary Completion: May 18, 2022
• Study Completion: June 14, 2022
• Last Updated: December 2, 2025
• Results First Posted: June 13, 2023

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)