Mesenchymal TumorPhase 1/2NCT00592345
High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
A Phase 1/2 study testing Proton Beam Radiation, Photon Beam Radiation and Interoperative radiation in people with Mesenchymal Tumor, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of high dose radiation administered by both proton and photon therapy. Radiation is an effective treatment for many types of tumors and it is thought that radiation alone, when given in much higher doses over a shorter period of time, may be more effective in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesenchymal Tumor
- What is being tested?
- Proton Beam Radiation, Photon Beam Radiation and Interoperative radiation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 1999to Mar 2016
- Phase
- Phase 1/2
- 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
- Pathological diagnosis of malignant mesenchymal tumor of the thoracic/lumbar/spine/sacrum or paraspinal soft tissues involving nerve roots or extending into spinal canal. Inter-osseous bone sarcomas are to be managed by wide resectional surgery for patients that are medically operable.
- Patient tumor status: 1) post biopsy or post resection with gross residual disease 2) post grossly complete resection but with margins positive or very close or tumor spill or cut through
- Lesion may be primary or recurrent after prior surgery
- No clinical, radiographic or other evidence of distant metastasis
- Fit for the exposure of the affected vertebral segment
- Life expectancy of greater than 36 months
Show all 10Show fewer
- KPS equal to or greater than 70
- 18 years of age or older
- Declines radical surgery
- No prior radiation treatment to the affected spine region
Who cannot join
- Pregnancy
- Disease/conditions characterized by high radiation sensitivity. These include genetic diseases, such as ataxia telangiectasia. Major local conditions which are the local tolerance viz., multiple surgical procedures, serious local injuries.
- No evident cord/cauda malfunction for causes other than effects of local tumor growth or due to metabolic effects of tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to test the effectiveness of high dose radiation administered by both proton and photon therapy. Radiation is an effective treatment for many types of tumors and it is thought that radiation alone, when given in much higher doses over a shorter period of time, may be more effective in controlling recurrence of sarcoma.
Read the detailed description
- In this study three types of radiation will be used: standard radiation (called photon); alternative form of radiation called proton beam therapy; and a localized radiation applicator plaque that can be applied to the surface of the dura (the fibrous outer envelope that surrounds the spinal cord and fluid surrounding the spinal cord) at time of surgical removal of the tumor.
- Radiation treatments (photon and proton) and possibly surgical removal of portions of the tumor with intraoperative radiation delivery to the surface dura with intraoperative radiation delivery will be performed over a period of 12 weeks. As part of the treatment planning process, participants will need two treatment planning CT scans and 2-3 treatment planning sessions.
- Participants will receive, in total, 39-43 photon/proton treatments.
- Conditions
- Mesenchymal Tumor
- Being tested
- Proton Beam Radiation, Photon Beam Radiation, Interoperative radiation
- Keywords
- sarcoma of the thoracic/lumbar/spine/sacrum, paraspinal soft tissues, proton radiation therapy, photon radiation therapy, radiation applicator plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam RadiationRadiation
Administered over a period of 12 weeks.
Photon Beam RadiationRadiation
Administered over a period of 12 weeks.
Interoperative radiationRadiation
Radioactive plaque applied at the time of surgical removal of the tumor.
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population.
Measured: 3 years
Secondary outcomes (1)
To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment.
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 posted14 Jan 2008 (estimated)
- Study startMay 1999
- Primary completionMar 2005
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal TumorStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom DeLaney, MD, Massachusetts General Hospital
- Investigators
- Thomas F. DeLaney, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592345
- Sponsor's protocol ID
- 97-502
- Status last verified
- Feb 2017
- First submitted
- 28 Dec 2007
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Proton/Photon RT + Surgery of Sarcomas of the Thoracic, Lumbar Spine/Sacrum
- ClinicalTrials.gov ID
- NCT00592345
- Acronym / sponsor ID
- 97-502
- Conditions
- Mesenchymal Tumor
- Keywords
- sarcoma of the thoracic/lumbar/spine/sacrum, paraspinal soft tissues, proton radiation therapy, photon radiation therapy, radiation applicator plaque
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 1999
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Jan 2008 (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.
The purpose of this study is to test the effectiveness of high dose radiation administered by both proton and photon therapy. Radiation is an effective treatment for many types of tumors and it is thought that radiation alone, when given in much higher doses over a shorter period of time, may be more effective in controlling recurrence of sarcoma.
Detailed description
- In this study three types of radiation will be used: standard radiation (called photon); alternative form of radiation called proton beam therapy; and a localized radiation applicator plaque that can be applied to the surface of the dura (the fibrous outer envelope that surrounds the spinal cord and fluid surrounding the spinal cord) at time of surgical removal of the tumor.
- Radiation treatments (photon and proton) and possibly surgical removal of portions of the tumor with intraoperative radiation delivery to the surface dura with intraoperative radiation delivery will be performed over a period of 12 weeks. As part of the treatment planning process, participants will need two treatment planning CT scans and 2-3 treatment planning sessions.
- Participants will receive, in total, 39-43 photon/proton treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathological diagnosis of malignant mesenchymal tumor of the thoracic/lumbar/spine/sacrum or paraspinal soft tissues involving nerve roots or extending into spinal canal. Inter-osseous bone sarcomas are to be managed by wide resectional surgery for patients that are medically operable.
- Patient tumor status: 1) post biopsy or post resection with gross residual disease 2) post grossly complete resection but with margins positive or very close or tumor spill or cut through
- Lesion may be primary or recurrent after prior surgery
- No clinical, radiographic or other evidence of distant metastasis
- Fit for the exposure of the affected vertebral segment
Key exclusion criteria (3 listed)
- Pregnancy
- Disease/conditions characterized by high radiation sensitivity. These include genetic diseases, such as ataxia telangiectasia. Major local conditions which are the local tolerance viz., multiple surgical procedures, serious local injuries.
- No evident cord/cauda malfunction for causes other than effects of local tumor growth or due to metabolic effects of tumor
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 Beam RadiationAdministered over a period of 12 weeks. | Radiation | – |
| Photon Beam RadiationAdministered over a period of 12 weeks. | Radiation | – |
| Interoperative radiationRadioactive plaque applied at the time of surgical removal of the tumor. | Radiation | – |
Primary outcome
To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population.
Time frame: 3 years
1 secondary outcome
To evaluate the acute and later tolerance in 50 patients of high dose proton/photon radiation treatment.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
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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.
Thomas F. DeLaney, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Proton Beam Radiation, Photon Beam Radiation and Interoperative radiation in people with Mesenchymal Tumor, run by Massachusetts General Hospital 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 10 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: finished, as of the sponsor's last update on 3 Feb 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To define the efficacy of high dose fractionated radiation alone or combined with surgery in this patient population. (time frame: 3 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 3 Feb 2017.