NCT03819985

Brief Summary

This phase II trial studies the wound complication risk of shorter course, hypofractionated pre-surgery radiation therapy in treating patients with localized soft tissue sarcoma of the extremity of superficial trunk that can be removed by surgery. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Shorter course hypofractionated pre surgery radiation therapy may be more convenient for patients with soft tissue sarcoma than a longer course of radiation therapy, and may result in fewer complications.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
16mo left

Started Dec 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Dec 2018Aug 2027

Study Start

First participant enrolled

December 17, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

8.7 years

First QC Date

January 25, 2019

Last Update Submit

March 3, 2026

Conditions

Stage IA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage IB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Resectable Soft Tissue SarcomaStage I Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Outcome Measures

Primary Outcomes (1)

  • Time to a major wound complication (MWC)

    A Bayesian approach for the analysis of a stopping rule of higher acute wound complications for the new dose (E) will be employed.

    Up to 120 days after surgery

Secondary Outcomes (9)

  • Local recurrence free survival

    Up to 10 years after radiation therapy

  • Disease free survival (DFS) time

    Up to 10 years after radiation therapy

  • Time to relapse

    Up to 10 years after radiation therapy

  • Disease specific survival time

    Up to 10 years after radiation therapy

  • Pattern of local relapse (in radiation field, margin of field, out of radiation field)

    Up to 10 years after radiation therapy

  • +4 more secondary outcomes

Study Arms (1)

Treatment (hypofractionated RT)

EXPERIMENTAL

Patients receive hypofractionated radiation therapy in 15 daily fractions over 3 weeks in the absence of disease progression or unacceptable toxicity.

Radiation: Hypofractionated Radiation TherapyOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Questionnaire AdministrationOTHER

Ancillary studies

Treatment (hypofractionated RT)
Hypofractionated Radiation TherapyRADIATION

Undergo hypofractionated RT

Also known as: Hypofractionated Radiotherapy, Hypofractionated
Treatment (hypofractionated RT)
Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment
Treatment (hypofractionated RT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tumor located in the soft tissues of the extremities or superficial trunk
  • Deemed a candidate for complete macroscopic resection of the primary sarcoma
  • Histologically confirmed sarcoma arising in soft tissue
  • Patient may have had excisional biopsy of all gross disease at an outside facility with positive or uncertain resection margins and still be eligible if the evaluating sarcoma surgeon in the participating institution recommends oncologic re-resection of the surgical bed to obtain negative margins after a course of neoadjuvant irradiation (a sandwich approach of marginal excision--\>radiation therapy(RT)--\> wide excision, as per our standard practice)
  • No evidence of nodal or distant metastases as determined by clinical examination or any form of imaging
  • Has provided written informed consent for participation in this trial
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
  • Life expectancy greater than 6 months
  • Patients capable of childbearing are using adequate contraception
  • Available for follow-up

You may not qualify if:

  • Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be encompassed by the radiation field needed to treat the current sarcoma. In other words, treatment on this trial would require re-irradiation of tissues
  • Patients with nodal or distant metastases
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Bishop AJ, Mitra D, Farooqi A, Swanson DM, Hempel C, Willis T, Pearlnath C, Wang WL, Ratan R, Somaiah N, Benjamin RS, Torres KE, Hunt KK, Scally CP, Keung EZ, Satcher RL, Bird JE, Lin PP, Moon BS, Lewis VO, Roland CL, Guadagnolo BA. Moderately hypofractionated, preoperative radiotherapy in patients with soft tissue sarcomas (HYPORT-STS): Updated local control, late toxicities, and patient-reported outcomes. Cancer. 2025 Jan 1;131(1):e35542. doi: 10.1002/cncr.35542. Epub 2024 Aug 27.

    PMID: 39192597DERIVED

  • Guadagnolo BA, Bassett RL, Mitra D, Farooqi A, Hempel C, Dorber C, Willis T, Wang WL, Ratan R, Somaiah N, Benjamin RS, Torres KE, Hunt KK, Scally CP, Keung EZ, Satcher RL, Bird JE, Lin PP, Moon BS, Lewis VO, Roland CL, Bishop AJ. Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2022 Dec;23(12):1547-1557. doi: 10.1016/S1470-2045(22)00638-6. Epub 2022 Nov 4.

    PMID: 36343656DERIVED

Related Links

MeSH Terms

Interventions

Radiation Dose Hypofractionation

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Beverly A Guadagnolo

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 29, 2019

Study Start

December 17, 2018

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

US(1)