Soft Tissue SarcomaNCT02706171
Stereotactic Radiosurgery for Soft Tissue Sarcoma
A study testing CyberKnife in people with Soft Tissue Sarcoma, run by The Cooper Health System at 1 site in United States.
Trial summary
This study is evaluating treatment with CyberKnife for soft tissue sarcomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- CyberKnife
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All cohorts:
- Age > 18
- Patients of child-bearing age must agree to contraception until radiosurgery has been completed.
- Note that patients with metastatic disease are eligible for protocol
- Cohort 1: Soft tissue sarcoma (of any histology subtype) in patients that are -planned to have pre-operative radiation followed by surgical resection
- Anatomical site to include upper extremity (including shoulder) and lower extremity (including hip)
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- Patient performance status and co-morbid conditions to allow for surgical resection
- Cohort 2: soft tissue sarcoma (of any histologic subtype) post-resection with no further plans for additional surgery.
- Patients must have high risk feature requiring post-operative radiation which can include Large tumor (> 5 cm), High grade, Previous unplanned, non, oncologic surgery, Close margins
- Anatomical site to include upper extremity (including shoulder) and lower extremity (including hip)
- Cohort 3: soft tissue sarcoma (of any histologic subtype) that is not amenable to surgical resection for any reason
- Anatomical site to include upper extremity (including shoulder) and lower extremity (including hip and pelvis)
- Patients cannot have planned surgical resection
- Note that retroperitoneal sarcomas are not eligible
Who cannot join
- -Tumors that do not fit criteria for any of the above cohorts
Trial locations and contacts
1 site in 1 country.
United States1 site
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
About this study
This study is evaluating treatment with CyberKnife for soft tissue sarcomas.
Read the detailed description
Because of these possible advantages of SBRT over conventional radiation, the investigators began a small pilot study to test this new treatment technique in the setting of resectable soft tissue sarcomas. The pilot study was planned for a total of 12 patients which was felt to be a good number to gauge if further expansion of this technology would be successful. As of 2/6/2015 13 participants have enrolled (two enrolled patients declined treatment on protocol and thus a total of 11 patients have been treated on protocol). As of this time, the investigators have not had seen Grade 3 or higher toxicity and no instance of local failure. There have been several distant failures which would not be related to local therapy like SBRT and if anything, SBRT should reduce instance of distant failure by shortening time to chemotherapy.
The following represents the initial experience for SBRT for STS (from manuscript submitted for publication). Note that on the below abstract 8 participants were treated on the pilot study while 5 participants were treated prior to pilot study opening (the one instance of local failure is from patient treated pre-protocol).
In terms of patient numbers the goal is to have 33 patients in cohorts one and two. Using historical controls of late toxicity rates of 40% and late toxicity rates in the initial population of 20% with an alpha of 0.1 (which is reasonable for phase II studies, an alpha of 0.05 is typical for phase III studies) there would be 80% power to detect a difference with 33 patients.
The expectation for this phase II study includes the following
- Late toxicity 30% or less
- Local control rates 90% or better
These numbers are based on historical controls and previous research. Local control rates for historical series have been 90% or better and this also held true in the initial phase II study. For late toxicity rates, historical controls are 35-43% (The NCI study that used similar wound complication definitions to us and was a well powered study had a wound complication rate of 43%). The investigators feel that for this study to be promising enough for large phase III non-inferiority studies that the current phase II study should have late toxicity rates of 30% or better and local control rates of 90% or better.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- CyberKnife
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyberKnifeRadiation
Also called CK
| Study group | Role | What they receive |
|---|---|---|
| A: pre-operative | Experimental | Radiation- CyberKnife:
35-40 Gy over 5 fractions
Surgery:
Surgical resection of sarcoma Receives: Radiation: CyberKnife |
| B: Post-operative | Experimental | Radiation- CyberKnife:
40 Gy over 5 fractions Receives: Radiation: CyberKnife |
| C: Non-resectable | Experimental | Radiation- CyberKnife:
50 Gy over 5 fractions Receives: Radiation: CyberKnife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1-2 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 year
Progression Free Survival
Measured: 5 years
Secondary outcomes (2)
change in tumor burden by RECIST 1.1 response assessment
Measured: 1-2 months, 4 months
overall survival
Measured: 6 months, 1 year, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706171
- Sponsor's protocol ID
- 15-073
- Status last verified
- Mar 2024
- First submitted
- 2 Oct 2015
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Kubicek GJ, Kim TW, Gutowski CJ, Kaden M, Eastwick G, Khrizman P, Xu Q, Lackman R. Preoperative Stereotactic Body Radiation Therapy for Soft-Tissue Sarcoma: Results of Phase 2 Study. Adv Radiat Oncol. 2021 Nov 20;7(2):100855. doi: 10.1016/j.adro.2021.100855. eCollection 2022 Mar-Apr.
PubMed 35387414
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Radiosurgery for Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT02706171
- Acronym / sponsor ID
- 15-073
- Conditions
- Soft Tissue Sarcoma
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 11 Mar 2016 (estimated)
- 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.
This study is evaluating treatment with CyberKnife for soft tissue sarcomas.
Detailed description
Because of these possible advantages of SBRT over conventional radiation, the investigators began a small pilot study to test this new treatment technique in the setting of resectable soft tissue sarcomas. The pilot study was planned for a total of 12 patients which was felt to be a good number to gauge if further expansion of this technology would be successful. As of 2/6/2015 13 participants have enrolled (two enrolled patients declined treatment on protocol and thus a total of 11 patients have been treated on protocol). As of this time, the investigators have not had seen Grade 3 or higher toxicity and no instance of local failure. There have been several distant failures which would not be related to local therapy like SBRT and if anything, SBRT should reduce instance of distant failure by shortening time to chemotherapy.
The following represents the initial experience for SBRT for STS (from manuscript submitted for publication). Note that on the below abstract 8 participants were treated on the pilot study while 5 participants were treated prior to pilot study opening (the one instance of local failure is from patient treated pre-protocol).
In terms of patient numbers the goal is to have 33 patients in cohorts one and two. Using historical controls of late toxicity rates of 40% and late toxicity rates in the initial population of 20% with an alpha of 0.1 (which is reasonable for phase II studies, an alpha of 0.05 is typical for phase III studies) there would be 80% power to detect a difference with 33 patients.
The expectation for this phase II study includes the following
- Late toxicity 30% or less
- Local control rates 90% or better
These numbers are based on historical controls and previous research. Local control rates for historical series have been 90% or better and this also held true in the initial phase II study. For late toxicity rates, historical controls are 35-43% (The NCI study that used similar wound complication definitions to us and was a well powered study had a wound complication rate of 43%). The investigators feel that for this study to be promising enough for large phase III non-inferiority studies that the current phase II study should have late toxicity rates of 30% or better and local control rates of 90% or better.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: pre-operative | Experimental | Radiation: CyberKnifeRadiation- CyberKnife: 35-40 Gy over 5 fractions Surgery: Surgical resection of sarcoma |
| B: Post-operative | Experimental | Radiation: CyberKnifeRadiation- CyberKnife: 40 Gy over 5 fractions |
| C: Non-resectable | Experimental | Radiation: CyberKnifeRadiation- CyberKnife: 50 Gy over 5 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- All cohorts:
- Age > 18
- Patients of child-bearing age must agree to contraception until radiosurgery has been completed.
- Note that patients with metastatic disease are eligible for protocol
- Cohort 1: Soft tissue sarcoma (of any histology subtype) in patients that are -planned to have pre-operative radiation followed by surgical resection
Key exclusion criteria (1 listed)
- -Tumors that do not fit criteria for any of the above cohorts
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 |
|---|---|---|
| CyberKnifeAlso: CK | Radiation | A: pre-operative, B: Post-operative, C: Non-resectable |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1-2 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Progression Free Survival
Time frame: 5 years
2 secondary outcomes
change in tumor burden by RECIST 1.1 response assessment
Time frame: 1-2 months, 4 months
overall survival
Time frame: 6 months, 1 year, 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 35387414Kubicek GJ, Kim TW, Gutowski CJ, Kaden M, Eastwick G, Khrizman P, Xu Q, Lackman R. Preoperative Stereotactic Body Radiation Therapy for Soft-Tissue Sarcoma: Results of Phase 2 Study. Adv Radiat Oncol. 2021 Nov 20;7(2):100855. doi: 10.1016/j.adro.2021.100855. eCollection 2022 Mar-Apr.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyberKnife in people with Soft Tissue Sarcoma, run by The Cooper Health System 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 14 inclusion and 1 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: withdrawn, as of the sponsor's last update on 15 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 1-2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02706171, which also lists 1 linked publication.
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 15 Mar 2024.