Soft Tissue SarcomasPhase 2NCT04506008
Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
A Phase 2 study testing Ultra-Hypo-fractionation Radiotherapy, Resection and Questionnaire Administration in people with Soft Tissue Sarcomas, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcomas
- What is being tested?
- Ultra-Hypo-fractionation Radiotherapy, Resection and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
- ECOG performance status 0-2
- Patient must be deemed able to comply with radiation treatment and surgery
Who cannot join
- History of prior radiation to the same area to be irradiated
- Pregnancy
- Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Service for Timely Access, 800-811-8480, cip@vumc.org
Eric Shinohara, MD
About this study
Official title: Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.
Read the detailed description
Study Objectives:
Primary:
- To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control
- Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.
OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.
GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.
GROUP II (MODERATE HYPOFRACTIONATION [MH]): Patients undergo HRT daily for a total of 15 fractions followed by surgery.
After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.
- Conditions
- Soft Tissue Sarcomas
- Being tested
- Ultra-Hypo-fractionation Radiotherapy, Resection, Questionnaire Administration, Moderately-Hypo-fractionation Radiotherapy
- Keywords
- Hypofractionated Radiotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-Hypo-fractionation RadiotherapyRadiation
Five fractions of pre-operative radiation
ResectionProcedure or surgery
Surgery
Questionnaire AdministrationOther
Ancillary studies
Moderately-Hypo-fractionation RadiotherapyRadiation
15 fractions of pre-operative radiation
| Study group | Role | What they receive |
|---|---|---|
| Group I (UH HRT) | Experimental | Patients undergo HRT daily for a total of 5 fractions followed by surgery. Receives: Radiation: Ultra-Hypo-fractionation Radiotherapy; Procedure: Resection; Other: Questionnaire Administration |
| Group II (MH HRT) | Experimental | Patients undergo HRT daily for a total of 15 fractions followed by surgery. Receives: Procedure: Resection; Other: Questionnaire Administration; Radiation: Moderately-Hypo-fractionation Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.
Measured: Approximately 2 years
Secondary outcomes (1)
Complication rate
The complication rate will be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. The complication rate will also be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study.
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start2 Mar 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Shinohara, Vanderbilt-Ingram Cancer Center
- Investigators
- Eric Shinohara, MD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506008
- Sponsor's protocol ID
- VICC SAR 2062
- Status last verified
- Mar 2025
- First submitted
- 5 Aug 2020
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Trial of Two Neoadjuvant Hypofractionated Radiotherapy Regimens Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT04506008
- Acronym / sponsor ID
- VICC SAR 2062
- Conditions
- Soft Tissue Sarcomas
- Keywords
- Hypofractionated Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.
Detailed description
Study Objectives:
Primary:
- To investigate the efficacy of neoadjuvant hypo-fractionated radiotherapy (HRT) followed by surgical resection in the treatment of soft tissue sarcoma (STS) as measured by local control
- Examine the side effect profile using Radiation Therapy Oncology Group (RTOG) and Common Terminology Criteria for Adverse Events (CTCAE) acute and late side effects criteria and major and minor post-operative complication rates.
OUTLINE: Patients are assigned to 1 of 2 groups by the radiation oncologist.
GROUP I (ULTRA-HYPOFRACTIONATION [UH]): Patients undergo HRT daily for a total of 5 fractions followed by surgery.
GROUP II (MODERATE HYPOFRACTIONATION [MH]): Patients undergo HRT daily for a total of 15 fractions followed by surgery.
After completion of study treatment, patients are followed up within 3 months, then every 3-6 months for a minimum of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (UH HRT) | Experimental | Radiation: Ultra-Hypo-fractionation Radiotherapy, Procedure: Resection, Other: Questionnaire AdministrationPatients undergo HRT daily for a total of 5 fractions followed by surgery. |
| Group II (MH HRT) | Experimental | Procedure: Resection, Other: Questionnaire Administration, Radiation: Moderately-Hypo-fractionation RadiotherapyPatients undergo HRT daily for a total of 15 fractions followed by surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)
- ECOG performance status 0-2
- Patient must be deemed able to comply with radiation treatment and surgery
Key exclusion criteria (3 listed)
- History of prior radiation to the same area to be irradiated
- Pregnancy
- Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra-Hypo-fractionation RadiotherapyFive fractions of pre-operative radiation | Radiation | Group I (UH HRT) |
| ResectionSurgery | Procedure or surgery | Group I (UH HRT), Group II (MH HRT) |
| Questionnaire AdministrationAncillary studies | Other | Group I (UH HRT), Group II (MH HRT) |
| Moderately-Hypo-fractionation Radiotherapy15 fractions of pre-operative radiation | Radiation | Group II (MH HRT) |
Primary outcome
Local control rate
Time frame: Approximately 2 years
Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.
1 secondary outcome
Complication rate
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Shinohara, MD principal investigator
Vanderbilt Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultra-Hypo-fractionation Radiotherapy, Resection and Questionnaire Administration in people with Soft Tissue Sarcomas, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanderbilt-Ingram Service for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.