Soft Tissue Sarcoma of the ExtremitiesPhase 2NCT01561495
Proton Radiotherapy for Extremity Soft Tissue Sarcoma
A Phase 2 study testing Proton Therapy in people with Soft Tissue Sarcoma of the Extremities, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a study of proton radiotherapy for the pre- or post- operative treatment of patients with extremity sarcoma. This study will treat patients in two dose groups: 1. patients receiving pre-operative proton therapy and 2. patients receiving post-operative proton therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma of the Extremities
- What is being tested?
- Proton Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to 3 Feb 2017
- Phase
- Phase 2
- 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
- Patients with a histologic diagnosis of soft tissue sarcoma of the extremities are eligible for this study.
- Patient must be 18 years of age.
- Patients must have evidence of disease limited to the extremities.
- For the pre-operative group, patients must be considered operable/resectable and a candidate for pre-operative radiotherapy as judged by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. All patients in the pre-operative group will be evaluated for this protocol PRIOR to the initiation of therapy.
- For the post-operative group, patients must be considered operable/resectable (if evaluated prior to resection) and a candidate for post-operative radiotherapy by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. Patients in the post-operative group may be evaluated PRIOR to the initiation of any therapy or may be referred for evaluation after surgical resection.
- ECOG status of 0-2.
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- Patients must sign a document that indicates that they are aware of the investigative nature of the treatment of this protocol, and the potential benefits and risks. Patients unwilling or unable to sign informed consent are excluded from the study.
- Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.
- Negative urine pregnancy test for females of childbearing potential on the day of the F18-EF5 PET scan prior to F18-EF5 injection
Who cannot join
- Pregnant women, women planning to become pregnant and women that are nursing.
- Patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19004
About this study
This is a study of proton radiotherapy for the pre- or post- operative treatment of patients with extremity sarcoma. This study will treat patients in two dose groups:
- patients receiving pre-operative proton therapy and
- patients receiving post-operative proton therapy. In each dose group, the study is divided into two phases. In the first phase of the study, the investigators will determine if treatment with proton therapy is safe and can be delivered on a regular basis. In the second phase, the investigators will determine if proton therapy has less long term side effects compared to standard radiation in both pre-operative patients and post-operative patients.
Read the detailed description
This study will be performed in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second part will begin no earlier than 30 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified.
The primary objective of this study is feasibility. The study will be deemed infeasible if 10% or more of patients experience one of the following:
- Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised (95% of planning target volume covered by 95% of the dose).
- Patient is unable to tolerate more than 25% of treatments (for any reasonable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using proton radiotherapy. Note: this end-point is proton-therapy specific, and indicates feasibility of proton as opposed to photon radiotherapy. For example, if the proton-specific patient immobilization/positioning is not well tolerated or extra time in the treatment position is too long or uncomfortable, protons delivered per protocol would be deemed not feasible compared to photons. Any treatments that cannot be delivered with protons will be delivered using photons, so that the patient receives the prescribed tumor dose.
- Patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion or requires a treatment break greater than 5 days. Additionally, no greater than 33% of patients experience a significant toxicity.
Primary Objectives for second phase of study are:
- The primary objective of Phase II in the pre-operative group will be to evaluate the wound complication rate of pre-operative proton radiotherapy in patients with STS of the lower extremity.
- The primary objective of Phase II in the post-operative group will be to evaluate the functional outcome (e.g., fibrosis, joint stiffness, edema) at two years after post-operative proton radiotherapy in patients with STS of the lower extremity.
Secondary Objectives for both phases of study are:
- To assess the local control rate, progression-free survival and overall survival of proton radiotherapy for STS of the extremity.
- To determine the acute and late toxicities of proton radiotherapy to the extremities.
- To monitor for effects of proton treatment on tumor and normal tissues using radiographic imaging (both cohorts) or ex-vivo analysis of tissue samples (pre-operative cohort only).
- To examine the relationship between pre-treatment hypoxia as determined by F18-EF5 scanning and treatment outcome.
- Conditions
- Soft Tissue Sarcoma of the Extremities
- Being tested
- Proton Therapy
- Keywords
- scheduled to receive RT either pre- or postoperatively
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton TherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Proton Radiotherapy Receives: Radiation: Proton Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Given this is initially a feasibility study- the primary measure is number of AEs (Adverse Events).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJun 2010
- Primary completion3 Feb 2017
- Study completion3 Feb 2017
Why it stopped: Sponsor Request- Global low enrollment
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 Soft Tissue Sarcoma of the ExtremitiesStudies 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Curtiland Deville, MD, Principal investigator, Johns Hopkins Kimmel Cancer Center at Sibley Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561495
- Sponsor's protocol ID
- UPCC 09510
- Status last verified
- Nov 2019
- First submitted
- 21 Mar 2012
- Last updated
- 6 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Radiotherapy for Extremity Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01561495
- Acronym / sponsor ID
- UPCC 09510
- Conditions
- Soft Tissue Sarcoma of the Extremities
- Keywords
- scheduled to receive RT either pre- or postoperatively
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Request- Global low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- 3 Feb 2017 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Posted 6 Dec 2019
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 study of proton radiotherapy for the pre- or post- operative treatment of patients with extremity sarcoma. This study will treat patients in two dose groups:
- patients receiving pre-operative proton therapy and
- patients receiving post-operative proton therapy. In each dose group, the study is divided into two phases. In the first phase of the study, the investigators will determine if treatment with proton therapy is safe and can be delivered on a regular basis. In the second phase, the investigators will determine if proton therapy has less long term side effects compared to standard radiation in both pre-operative patients and post-operative patients.
Detailed description
This study will be performed in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second part will begin no earlier than 30 days after the last patient in the initial phase has completed treatment and once safety and feasibility has been verified.
The primary objective of this study is feasibility. The study will be deemed infeasible if 10% or more of patients experience one of the following:
- Patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised (95% of planning target volume covered by 95% of the dose).
- Patient is unable to tolerate more than 25% of treatments (for any reasonable to set patient up within acceptable limits of tolerance, patient unable to tolerate treatment position or immobilization for duration of treatment) using proton radiotherapy. Note: this end-point is proton-therapy specific, and indicates feasibility of proton as opposed to photon radiotherapy. For example, if the proton-specific patient immobilization/positioning is not well tolerated or extra time in the treatment position is too long or uncomfortable, protons delivered per protocol would be deemed not feasible compared to photons. Any treatments that cannot be delivered with protons will be delivered using photons, so that the patient receives the prescribed tumor dose.
- Patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion or requires a treatment break greater than 5 days. Additionally, no greater than 33% of patients experience a significant toxicity.
Primary Objectives for second phase of study are:
- The primary objective of Phase II in the pre-operative group will be to evaluate the wound complication rate of pre-operative proton radiotherapy in patients with STS of the lower extremity.
- The primary objective of Phase II in the post-operative group will be to evaluate the functional outcome (e.g., fibrosis, joint stiffness, edema) at two years after post-operative proton radiotherapy in patients with STS of the lower extremity.
Secondary Objectives for both phases of study are:
- To assess the local control rate, progression-free survival and overall survival of proton radiotherapy for STS of the extremity.
- To determine the acute and late toxicities of proton radiotherapy to the extremities.
- To monitor for effects of proton treatment on tumor and normal tissues using radiographic imaging (both cohorts) or ex-vivo analysis of tissue samples (pre-operative cohort only).
- To examine the relationship between pre-treatment hypoxia as determined by F18-EF5 scanning and treatment outcome.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Radiation: Proton TherapyProton Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with a histologic diagnosis of soft tissue sarcoma of the extremities are eligible for this study.
- Patient must be 18 years of age.
- Patients must have evidence of disease limited to the extremities.
- For the pre-operative group, patients must be considered operable/resectable and a candidate for pre-operative radiotherapy as judged by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. All patients in the pre-operative group will be evaluated for this protocol PRIOR to the initiation of therapy.
- For the post-operative group, patients must be considered operable/resectable (if evaluated prior to resection) and a candidate for post-operative radiotherapy by the attending surgeon and radiation oncologist. The clinical evaluation of patients will include a work up as per the standard of care. Patients in the post-operative group may be evaluated PRIOR to the initiation of any therapy or may be referred for evaluation after surgical resection.
Key exclusion criteria (2 listed)
- Pregnant women, women planning to become pregnant and women that are nursing.
- Patients who experience surgical complications that prevent radiation from starting for 5 months or more, unless there is evidence of gross residual disease.
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 |
|---|---|---|
| Proton Therapy | Radiation | All Participants |
Primary outcome
Number of Adverse Events
Time frame: 4 years
Given this is initially a feasibility study- the primary measure is number of AEs (Adverse Events).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Curtiland Deville, MD principal investigator
Johns Hopkins Kimmel Cancer Center at Sibley Memorial Hospital
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 Proton Therapy in people with Soft Tissue Sarcoma of the Extremities, run by Abramson Cancer Center at Penn Medicine 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 9 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2019). 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 (time frame: 4 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 6 Dec 2019.