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Testing Short-Course Radiation Versus Standard-Course Radiation for Soft Tissue Sarcomas That Need Surgery and Radiation

ConditionsRecurrent Soft Tissue Sarcoma of the Trunk and ExtremitiesResectable Soft Tissue Sarcoma of the Trunk and ExtremitiesSoft Tissue Sarcoma of the Trunk and ExtremitiesStage II Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSWOG Cancer Research Network

About this trial

This clinical trial compares the effect of short-course ultrahypofractionated radiation therapy over 5 days (UHRT-5) to standard-course radiation therapy over 25 days (RT-25) in treating patients with soft tissue sarcomas of the extremities that may be primary or that may have come back to nearby tissue or lymph nodes after a period of improvement (locally recurrent) and that can be removed by surgery (resectable). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. 3-dimensional (3D) conformal radiation therapy (CRT) uses a computer to create a 3D picture of the tumor. This allows doctors to give the highest possible dose of radiation to the tumor, while sparing the normal tissue as much as possible. Intensity-modulated radiation therapy (IMRT) is a type of 3D radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Standard-course (fractionated) radiation divides the total dose of radiation therapy into several smaller, equal doses delivered over a period of several days. Ultrahypofractionated 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. Giving UHRT-5 may be as effective as RT-25 in treating patients with primary or locally recurrent soft tissue sarcomas of the extremities that are resectable. It may also improve quality of life by requiring fewer treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histological evidence of a soft tissue sarcoma from core or incisional biopsy. Participants must have a primary or locally recurrent tumor. Stage II-IIIB (by American Joint Committee on Cancer [AJCC] 8th edition) soft tissue sarcoma is required

Prior partial excision or partial excisional biopsy of the tumor, with imaging evidence of gross residual disease > 1cm in longest dimension (stage II-IIIB)

Participants must have a primary site of disease in the extremity, including the shoulder girdle and hip girdle but excluding the hands and feet

Participants with primary sites of trunk, head, neck, or intra-abdominal, intrapelvic, or retroperitoneal region are not eligible

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3-Dimensional Conformal Radiation Therapy

    Radiation

    Undergo RT-25 with 3D-CRT

  • 3-Dimensional Conformal Radiation Therapy

    Radiation

    Undergo UHRT-5 with 3D CRT

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo RT-25 with IMRT

  • Intensity-Modulated Radiation Therapy

    Radiation

    Undergo UHRT-5 with IMRT

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Surgical Procedure

    Procedure/Surgery

    Undergo surgical resection

Treatment groups

296 Participants
are divided into 2 treatment groups
Group A: Arm 1 (RT-25)Active comparator 6 interventions
Group B: Arm 2 (UHRT-5)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Local tumor recurrence rate

Cumulative incidence of local tumor recurrence will be estimated non-parametrically with death from any cause analyzed as a competing risk. 2-year estimates of local tumor recurrence and standard errors will be calculated and used to calculate a one-sided 95% confidence internal for the difference in 2-year local tumor recurrence rates.

Time frame
At 2 years

Secondary outcomes

1

Incidence of acute wound complications

Will be estimated in each arm with 95% exact confidence intervals and compared using Fisher's exact test.

Time frame
Up to 4 months after surgery
2

Incidence of late-term complications associated with radiation

Will be estimated in each arm with 95% exact confidence intervals and compared using Fisher's exact test.

Time frame
Up to 2 years post-surgery
3

Changes in physician-assessed functional outcome

Will be evaluated using the Musculoskeletal Tumor Society Scoring system.

Time frame
From pre-randomization up to 24 months post-surgery
4

Overall survival

Will be estimated in each arm and compared using log-rank tests.

Time frame
From randomization up to 10 years

Other outcomes

1

Incidence of local tumor recurrence

Will estimate and compare between arms using a per-protocol analysis and report with 95% confidence intervals. Will be estimated non-parametrically in each arm based on observed reporting of events without pooling/harmonizing of event times and descriptively reported.

Time frame
At 2 years
2

Incidence of delayed wound healing

Will estimate and compare between arms the incidence of delayed wound healing and report 95% confidence intervals and compare with Fisher's exact test.

Time frame
Up to 6 months post-surgery
3

Type of surgical resection

Will report the type of surgical resection by treatment arm, including limb-salvage versus amputation and margin status with exact 95% confidence intervals.

Time frame
At time of surgery
4

Use of supportive therapy medications given with radiation therapy

Will describe the use of supportive therapy medications given with radiation therapy separately by treatment arm.

Time frame
Up to 10 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SWOG Cancer Research Network

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: