Stage IV Adult Soft Tissue SarcomaNCT01949506
(SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
A study testing SBRT in people with Stage IV Adult Soft Tissue Sarcoma and Sarcoma,Soft Tissue, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a prospective study to document the local control rates with SBRT specifically for pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute and late toxicity, quality of life (QoL), tumor control, and survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Adult Soft Tissue Sarcoma, Sarcoma,Soft Tissue
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2013to 4 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- ≥18 years of age
- Pathologic confirmation of primary soft tissue sarcoma with pathologic or radiographic evidence of pulmonary metastatic disease
- No evidence of extra pulmonary progression of disease for 3 months prior to enrollment on study
- 1-5 pulmonary lesions all ≤5 cm in size
- Medically inoperable or declines surgery
- Patients may have had previous treatment for pulmonary metastases
Who cannot join
- Patients who have uncontrolled extra-pulmonary disease
- Pregnant women
- Patients who have greater than 5 pulmonary lesions at the time of study enrollment
- Patients who have disease progression outside the lungs within 3 months of enrollment on the study
- Disease pathology other than sarcoma subtypes
- Patients with a history of metastatic disease from a primary other than sarcoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Pilot Study Evaluating Stereotactic Body Radiation Therapy (SBRT) and Adaptive Radiation Therapy (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
This is a prospective study to document the local control rates with SBRT specifically for pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute and late toxicity, quality of life (QoL), tumor control, and survival.
Read the detailed description
A total of no more than 20 people are expected to participate in this study at the Medical College of Wisconsin/Froedtert Hospital. Patients will be followed for three years.
The usual treatment for sarcomas that spread to the lungs is to remove the cancer with surgery. Patients who cannot have surgery or prefer not to have surgery, can receive radiation therapy. Standard radiation therapy involves several weeks of daily treatment sessions, although it is not as effective as surgery and may seriously damage normal surrounding lung tissue. Stereotactic body radiation therapy (SBRT) is a radiation treatment that gives fewer but higher doses of radiation than standard radiation. SBRT is used to treat metastases to the lung from many types of cancer but has not been used very often with patients who have metastatic disease to their lungs from sarcomas.
The purpose of this study is to test the possibility of SBRT to the lung for metastatic disease to the lung. This information will be used to find out if there are factors that can predict recovery or outcome of patients with metastatic disease to the lung from sarcoma. SBRT will consist of 1 to 3 treatments per week for a total of 3 to 5 treatments to each tumor until therapy is complete. After SBRT is completed, follow-up exams will occur 4-6 weeks from the completion of radiation treatment, every 3 months in year 1 and every 6 months for 2 years.
- Being tested
- SBRT
- Keywords
- Lung metastases, Radiation Therapy, Stereotactic Body Radiation Therapy, Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Stereotactic Body Radiation Therapy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy | Other | Arms: Stereotactic Body Radiation Therapy (SBRT) with Adaptive Radiation Therapy (ART) for all patients. A non-randomized study. Patients must have 1-5 pulmonary metastases all less than 5 cm in size. Pathologic confirmation of primary soft tissue sarcoma. All lesions to receive 3-5 fractions to each tumor. Treatments delivered with > 10 Gy per fraction will have a minimum of 48 hour interfraction interval. For treatments with ≤ 10 Gy per fraction will have a minimum 24 hour interfraction interval. Treatments will be ideally completed over 14 days for 3 fraction treatments and over 21 days for >5 fraction treatment schedules. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria.
This measure (number of adverse events of grade ≥ 3 by Common Terminology Criteria for Adverse Events (CTCAE) criteria) will provide information regarding the acute toxicity of SBRT for < 5 pulmonary metastases from soft tissue sarcoma..The CTCAE criteria provide a standardized description of adverse events including guidelines for grading severity. The guidelines can be viewed at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm.
Measured: 6 weeks post SBRT
Secondary outcomes (1)
Number of Subjects Experiencing Locoregional Recurrences.
This measure (number of subjects experiencing locoregional recurrences) will provide information regarding locoregional control. Locoregional recurrence means any new or renewed tumor growth of any size observed by an imaging technology that is located at or adjacent to a prior treatment site.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study start24 Sep 2013
- Primary completion4 Oct 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage IV Adult Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meena Bedi, Medical College of Wisconsin
- Investigators
- Manpreet Bedi, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949506
- Sponsor's protocol ID
- PRO00020337
- Status last verified
- Jan 2023
- First submitted
- 4 Sep 2013
- Last updated
- 28 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Stereotactic Body Radiation Therapy (SBRT) and Adaptive Radiation Therapy (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
- ClinicalTrials.gov ID
- NCT01949506
- Acronym / sponsor ID
- PRO00020337
- Keywords
- Lung metastases, Radiation Therapy, Stereotactic Body Radiation Therapy, Sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 24 Sep 2013 (actual)
- Primary completion
- 4 Oct 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Posted 28 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study to document the local control rates with SBRT specifically for pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute and late toxicity, quality of life (QoL), tumor control, and survival.
Detailed description
A total of no more than 20 people are expected to participate in this study at the Medical College of Wisconsin/Froedtert Hospital. Patients will be followed for three years.
The usual treatment for sarcomas that spread to the lungs is to remove the cancer with surgery. Patients who cannot have surgery or prefer not to have surgery, can receive radiation therapy. Standard radiation therapy involves several weeks of daily treatment sessions, although it is not as effective as surgery and may seriously damage normal surrounding lung tissue. Stereotactic body radiation therapy (SBRT) is a radiation treatment that gives fewer but higher doses of radiation than standard radiation. SBRT is used to treat metastases to the lung from many types of cancer but has not been used very often with patients who have metastatic disease to their lungs from sarcomas.
The purpose of this study is to test the possibility of SBRT to the lung for metastatic disease to the lung. This information will be used to find out if there are factors that can predict recovery or outcome of patients with metastatic disease to the lung from sarcoma. SBRT will consist of 1 to 3 treatments per week for a total of 3 to 5 treatments to each tumor until therapy is complete. After SBRT is completed, follow-up exams will occur 4-6 weeks from the completion of radiation treatment, every 3 months in year 1 and every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy | Other | Radiation: SBRTArms: Stereotactic Body Radiation Therapy (SBRT) with Adaptive Radiation Therapy (ART) for all patients. A non-randomized study. Patients must have 1-5 pulmonary metastases all less than 5 cm in size. Pathologic confirmation of primary soft tissue sarcoma. All lesions to receive 3-5 fractions to each tumor. Treatments delivered with > 10 Gy per fraction will have a minimum of 48 hour interfraction interval. For treatments with ≤ 10 Gy per fraction will have a minimum 24 hour interfraction interval. Treatments will be ideally completed over 14 days for 3 fraction treatments and over 21 days for >5 fraction treatment schedules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age
- Pathologic confirmation of primary soft tissue sarcoma with pathologic or radiographic evidence of pulmonary metastatic disease
- No evidence of extra pulmonary progression of disease for 3 months prior to enrollment on study
- 1-5 pulmonary lesions all ≤5 cm in size
- Medically inoperable or declines surgery
Key exclusion criteria (6 listed)
- Patients who have uncontrolled extra-pulmonary disease
- Pregnant women
- Patients who have greater than 5 pulmonary lesions at the time of study enrollment
- Patients who have disease progression outside the lungs within 3 months of enrollment on the study
- Disease pathology other than sarcoma subtypes
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 |
|---|---|---|
| SBRTStereotactic Body Radiation Therapy | Radiation | Stereotactic Body Radiation Therapy |
Primary outcome
Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria.
Time frame: 6 weeks post SBRT
This measure (number of adverse events of grade ≥ 3 by Common Terminology Criteria for Adverse Events (CTCAE) criteria) will provide information regarding the acute toxicity of SBRT for < 5 pulmonary metastases from soft tissue sarcoma..The CTCAE criteria provide a standardized description of adverse events including guidelines for grading severity. The guidelines can be viewed at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm.
1 secondary outcome
Number of Subjects Experiencing Locoregional Recurrences.
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Manpreet Bedi, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT in people with Stage IV Adult Soft Tissue Sarcoma and Sarcoma,Soft Tissue, run by Medical College of Wisconsin 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 28 Feb 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria. (time frame: 6 weeks post SBRT). 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 Feb 2023.