Retroperitoneal SarcomaPhase 1/2NCT01659203
Proton or Photon RT for Retroperitoneal Sarcomas
A Phase 1/2 study testing IG-IMPT and IG IMRT in people with Retroperitoneal Sarcoma, run by Massachusetts General Hospital at 10 sites in United States.
Trial summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Sarcoma
- What is being tested?
- IG-IMPT and IG IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2012to 31 Dec 2027
- Phase
- Phase 1/2
- 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
- Histologically proven primary soft tissue sarcoma of the retroperitoneum
- Measurable disease
- Life expectancy of greater than 2 years
Who cannot join
- Prior radiation therapy for retroperitoneal sarcoma
- Pregnant or breastfeeding
- Chemotherapy within 4 weeks prior to entering study
- Receiving other investigational agents
- Other types of sarcomas
- Multifocal disease, lymph node or distant metastases
Show all 10Show fewer
- History of sensitivity to radiation therapy
- Uncontrolled intercurrent illness
- History of a different invasive malignancy within the past 3 years
- HIV positive on combination anti-retroviral therapy
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Thomas DeLaney, MD, 6177266876, tdelaney@partners.org
Thomas DeLaney, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Elizabeth Baldini, MD, MPH, 6177326310, ebaldini@partners.org
Elizabeth Baldini, MD, MPH
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Varun Chowdhry, MD, mailto:Varun.Chowdhry@RoswellPark.org
Varun Chowdhry, MD
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Dian Wang, MD, dian_wang@rush.edu
- Recruiting
Washington University School of Medicine Siteman Cancer Center West County
Creve Coeur, Missouri, 63141
Jeff Michalski, MD, jmichalski@radonc.wustl.edu
- Recruiting
Duke University
Durham, North Carolina, 27710
Trey Blazer, MD, trey.blazer@duke.edu
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Andrew Bishop, MD
Andrew Bishop, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Ivy Peterson, MD, petersen.ivy@mayo.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Ying Hitchcock, MD, ying.hitchcock@hci.utah.edu
- Recruiting
Washington University School of Medicine Siteman Cancer Center South County
St Louis, Missouri, 63129
Jeff Michalski, MD, jmichalski@radonc.wustl.edu
About this study
Official title: Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) With Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it.
Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor.
Read more
Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation.
In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor.
The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas.
Read the detailed description
While being screened to determine eligibility for this study you may choose to participate in an additional blood sample for circulating DNA and a genomic DNA sample.
Since we are looking for the highest dose of Radiation Therapy that can be administered safely without severe or unmanageable side effects in participants that have retroperitoneal sarcomas, not everyone who participates in this research study will receive the same dose of study therapy. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. Your study doctor will tell you which dose you will get.
Radiation planning is standard of care for all patients undergoing radiation therapy. Before you begin radiation therapy you will have a radiation planning CT scan of the tumor site. This scan will be in addition to the scans done in order to confirm your eligibility for this study. Doctors will use teh images from this scan to plan your radiation treatment.
You will receive radiation therapy every day Monday through Friday for about six weeks. You will receive study therapy as an outpatient. During radiation therapy, you will be seen by the study doctor once a week. Each visit will take about 15 minutes, and the following assessments will be completed: medical history, vital signs, body weight and assessments for any side effects you may be experiencing.
After the final dose of radiation therapy you will be assessed for side effects of radiation following your last dose and before surgery. The following assessments will be completed before your surgery at this visit: Chest CT, CT/MRI of the abdomen/pelvis and routine blood tests to check for overall health.
You will be seen for a follow-up visit within one month of discharge following surgery and again four months after the surgery. At the first follow-up visit, the following assessment will be completed: medical history, vital signs and body weight, questions about side effects and routine blood tests to check for overall health. At the four month follow up visit the following assessment will be completed: medical history, vital signs and body weight, chest CT and abdominal/pelvic CT.
After your four month follow-up visit, you will be seen twice yearly following radiation for the first five years and then once a year for the rest of your life.
- Conditions
- Retroperitoneal Sarcoma
- Being tested
- IG-IMPT, IG IMRT
- Keywords
- extraskeletal chondrosarcoma
- Medical subject headings
- Chondrosarcoma, Extraskeletal Myxoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IG-IMPTRadiation
Daily, Monday-Friday for about 6 weeks
IG IMRTRadiation
Daily, Monday-Friday for about 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm IMPT | Experimental | IG-IMPT with SIB to the high risk margin Receives: Radiation: IG-IMPT |
| Treatment Arm IMRT | Experimental | IG IMRT with SIB to the high risk margin Receives: Radiation: IG IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Determine MTD
To determine the maximum tolerated dose (MTD) of preoperative IG-IMPT or IMRTwith simultaneously integrated boost to the high risk margin of retroperitoneal sarcoma. This is mainly based on evaluation of acute toxicity profile of each participant.
Measured: 2 years
Phase II: Determine Local Control Rate
To determine the local control rate after the protocol treatment (IG-IMPT or IMRT MTD with simultaneously integrated boost to the high risk margin) followed by surgical resection.
Measured: 2 years
Secondary outcomes (4)
Overall Survival
To estimate overall survival
Measured: 2 years
Pathologic Response
To estimate pathologic response (percentage of necrosis and margin status, especially status of the high-risk margin)
Measured: 2 years
Tumor Response
To estimate the tumor response through the comparison of CT imaging before and after the protocol treatment.
Measured: 2 years
Progression-Free Survival Times
To assess progression-free survival times relative to surrogate biological endpoints in tissue and blood in each participant
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startDec 2012
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal SarcomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Roswell Park Cancer Institute, National Cancer Institute (NCI), Duke University, Rush University Medical Center, University of Utah, Washington University School of Medicine, Mayo Clinic
- Responsible party
- Principal investigator, Kevin X. Liu, MD, DPHIL, Massachusetts General Hospital
- Investigators
- Thomas F. DeLaney, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659203
- Sponsor's protocol ID
- 12-100
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2012
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) With Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas
- ClinicalTrials.gov ID
- NCT01659203
- Acronym / sponsor ID
- 12-100
- Conditions
- Retroperitoneal Sarcoma
- Keywords
- extraskeletal chondrosarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Roswell Park Cancer Institute, National Cancer Institute (NCI), Duke University, Rush University Medical Center, University of Utah, Washington University School of Medicine, Mayo Clinic
- Study start
- Dec 2012
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2012 (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 research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it.
Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor.
Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation.
In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor.
The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas.
Detailed description
While being screened to determine eligibility for this study you may choose to participate in an additional blood sample for circulating DNA and a genomic DNA sample.
Since we are looking for the highest dose of Radiation Therapy that can be administered safely without severe or unmanageable side effects in participants that have retroperitoneal sarcomas, not everyone who participates in this research study will receive the same dose of study therapy. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. Your study doctor will tell you which dose you will get.
Radiation planning is standard of care for all patients undergoing radiation therapy. Before you begin radiation therapy you will have a radiation planning CT scan of the tumor site. This scan will be in addition to the scans done in order to confirm your eligibility for this study. Doctors will use teh images from this scan to plan your radiation treatment.
You will receive radiation therapy every day Monday through Friday for about six weeks. You will receive study therapy as an outpatient. During radiation therapy, you will be seen by the study doctor once a week. Each visit will take about 15 minutes, and the following assessments will be completed: medical history, vital signs, body weight and assessments for any side effects you may be experiencing.
After the final dose of radiation therapy you will be assessed for side effects of radiation following your last dose and before surgery. The following assessments will be completed before your surgery at this visit: Chest CT, CT/MRI of the abdomen/pelvis and routine blood tests to check for overall health.
You will be seen for a follow-up visit within one month of discharge following surgery and again four months after the surgery. At the first follow-up visit, the following assessment will be completed: medical history, vital signs and body weight, questions about side effects and routine blood tests to check for overall health. At the four month follow up visit the following assessment will be completed: medical history, vital signs and body weight, chest CT and abdominal/pelvic CT.
After your four month follow-up visit, you will be seen twice yearly following radiation for the first five years and then once a year for the rest of your life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm IMPT | Experimental | Radiation: IG-IMPTIG-IMPT with SIB to the high risk margin |
| Treatment Arm IMRT | Experimental | Radiation: IG IMRTIG IMRT with SIB to the high risk margin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologically proven primary soft tissue sarcoma of the retroperitoneum
- Measurable disease
- Life expectancy of greater than 2 years
Key exclusion criteria (10 listed)
- Prior radiation therapy for retroperitoneal sarcoma
- Pregnant or breastfeeding
- Chemotherapy within 4 weeks prior to entering study
- Receiving other investigational agents
- Other types of sarcomas
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 |
|---|---|---|
| IG-IMPTDaily, Monday-Friday for about 6 weeks | Radiation | Treatment Arm IMPT |
| IG IMRTDaily, Monday-Friday for about 6 weeks | Radiation | Treatment Arm IMRT |
Primary outcome
Phase I: Determine MTD
Time frame: 2 years
To determine the maximum tolerated dose (MTD) of preoperative IG-IMPT or IMRTwith simultaneously integrated boost to the high risk margin of retroperitoneal sarcoma. This is mainly based on evaluation of acute toxicity profile of each participant.
Phase II: Determine Local Control Rate
Time frame: 2 years
To determine the local control rate after the protocol treatment (IG-IMPT or IMRT MTD with simultaneously integrated boost to the high risk margin) followed by surgical resection.
4 secondary outcomes
Overall Survival
Time frame: 2 years
Pathologic Response
Time frame: 2 years
Tumor Response
Time frame: 2 years
Progression-Free Survival Times
Time frame: 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 31 Jul 2026.
Related trials for Retroperitoneal Sarcoma
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Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Retroperitoneal Sarcoma, Liposarcoma
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A Phase 1 Study of Neoadjuvant Abemaciclib in Combination With Radiation Therapy for Liposarcomas
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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.
Thomas F. DeLaney, M.D. principal investigator
Massachusetts General Hospital
10 sites 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 IG-IMPT and IG IMRT in people with Retroperitoneal Sarcoma, run by Massachusetts General Hospital at 10 sites 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 10 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
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 Thomas DeLaney, MD (617-726-6876, tdelaney@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Determine MTD (time frame: 2 years). The study lists 2 primary outcomes in all. 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 31 Jul 2026.