SarcomaPhase 1NCT01746238
Bevacizumab/Doxorubicin/Radiation for Sarcoma
A Phase 1 study testing Bevacizumab, Doxorubicin and Radiation Therapy in people with Sarcoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main purpose of this study is to test the safety, tolerability, maximum tolerated dose, and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Bevacizumab, Doxorubicin and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2026
- Phase
- Phase 1
- 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
- Primary soft tissue sarcoma or isolated local recurrent sarcoma without prior radiation
- Histologically intermediate- or high-grade soft tissue sarcoma
- Determined by an expert sarcoma surgeon to have resectable disease located on the upper extremity, lower extremity, trunk, retroperitoneum or pelvis
- Primary tumor must be at least 5 cm in maximal diameter or an isolated local recurrence of any size
Who cannot join
- Metastatic disease
- Pregnant or breastfeeding
- Immunotherapy, chemotherapy, experimental therapy or radiotherapy within 4 weeks of first day of study drug dosing
- Previously received doxorubicin, any other anthracycline chemotherapy or bevacizumab
- Major surgery within 4 weeks before first day of study drug dosing
- Uncontrolled intercurrent illness
Show all 12Show fewer
- History of myocardial infarction, acute coronary syndromes, coronary angioplasty or coronary artery stenting within previous 6 months
- Other medical or psychiatric conditions that may interfere with study participation
- Known hypercoagulable disorder
- Known history of deep vein thrombosis or pulmonary embolus
- Presence of bleeding diathesis or coagulopathy
- Current use of therapeutic anticoagulants
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Phase I Trial of Bevacizumab, Metronomic Doxorubicin and Radiation Therapy for Resectable Soft Tissue Sarcoma
The main purpose of this study is to test the safety, tolerability, maximum tolerated dose, and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy.
Because bevacizumab is not considered standard therapy for sarcomas, it can only be given to subjects with sarcoma who are enrolled in this research study and may only be administered under the direction of doctors who are investigators in this research study.
Read more
This study is being done because sarcomas can recur after surgical resection (surgery for removal of the tumor), radiation therapy and chemotherapy. This recurrence can occur in the same location as the original tumor or in distant sites such as the lung. Thus better treatments are needed.
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, combination of drugs, or combination of drugs with radiation. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs and radiation is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved bevacizumab with doxorubicin and radiation for your type of cancer.
Read the detailed description
In order to determine if patients are eligible for this study patients will undergo some screening procedures, including a medical history, physical examination, performance status, assessment of tumor, chest CT scan, blood tests, urine test, electrocardiogram and echocardiogram. Patients will also undergo blood tests and a tumor biopsy to look for markers for your particular type of cancer.
If it is determined that patients are eligible to be in the study they will need to have a central venous line (CVL), peripherally inserted central catheter (PICC), or portacath placement. Doxorubicin administration requires a central venous line, peripherally inserted central catheter (PICC) or portacath to be placed to allow continuous infusion of this drug.
Since the investigators are looking for the highest tolerable dose of the study drug, bevacizumab, that can be administered safely without severe or unmanageable side effects in participants that have sarcoma, not everyone who participates in this research study will receive the same dose of the study drug. The dose patients get will depend on the number of participants who have been enrolled in the study and how well they have tolerated their doses. The dose of doxorubicin and radiation therapy will be the same for all subjects throughout the study.
Bevacizumab will be given as an intravenous infusion (IV). The first infusion will take about 90 minutes. All other bevacizumab infusions will take either 60 or 30 minutes, if tolerated. The first infusion will be given on a Monday (excluding holidays). Patients will receive the second infusion 2 weeks later and then every 2 weeks after that for a total of 3 doses.
Doxorubicin will be given as an intravenous infusion (IV). It will be given through a port via an infusion pump about the size of a large wallet that can fit into a front-pack or "fanny-pack" around their waist. This pump will be connected to their body. The nurses in the infusion room will start the pump and disconnect it after 4 days. The first bolus infusion take will be given 1-2 hours after their first bevacizumab infusion and will take about 30 minutes. This will be followed by a continuous IV infusion of doxorubicin over 4 days. The first bolus infusion will be given on a Monday (excluding holidays) and the continuous infusion will go until Thursday. Patients will receive a second bolus infusion followed by a 4 day continuous infusion every week for 5 weeks.
Patients will begin radiation therapy after their first bevacizumab and doxorubicin infusion on Monday (excluding holidays). Radiation therapy will be delivered five days per week (Monday through Friday-excluding holidays) over a period of 6 weeks. This is done as an outpatient procedure. Each 2-week period will be considered a separate treatment cycle. Patients will be treated with radiation therapy for a maximum of 3 cycles (6 weeks).
The following tests and procedures will be done during the study during weeks 2, 4 and 6 and before surgery: a medical history, physical examination, performance status, blood tests, urine tests and assessment for any side effects. Patients will have additional CT scans of their chest and tumor before surgery. An ECG will be repeated at this time.
A surgeon will evaluate the tumor by reviewing radiologic studies before study treatment to determine if surgical removal is possible. After patients complete study treatment with radiation therapy and bevacizumab, a surgeon will repeat the evaluation of the tumor by reviewing radiologic studies to determine if surgical removal is still possible. Patients will have surgery 6-7 weeks after they finish radiation therapy.
Patients will have additional radiation therapy if the research doctor thinks that some cancer cells may have been left in their body in the area where the tumor was removed. The radiation may be given while patients are in surgery or about two weeks after the surgery. This will be determined by the surgeon and or radiation oncologist.
Patients will be in this research study for about 3 months. After the last dose of the study drug the investigators would like to keep track of their medical condition for 10 years. The investigators would like to do this by calling patients by telephone once a year to see how they are doing. Keeping in touch with them and checking their condition every year helps the investigators look at the long term effects of the research study.
- Conditions
- Sarcoma
- Being tested
- Bevacizumab, Doxorubicin, Radiation Therapy
- Keywords
- soft tissue, high grade
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Intravenous infusion, every 2 weeks, 3 doses total
DoxorubicinDrug
Also called Adriamycin
Intravenous infusion, bolus infusion followed by 4 day continuous infusion, every week for 5 weeks
Radiation TherapyRadiation
Also called XRT
Daily, Monday-Friday, for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Bevacizumab, metronomic doxorubicin and radiation therapy Receives: Drug: Bevacizumab; Drug: Doxorubicin; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine MTD of bevacizumab+doxorubicin+radiation
To determine the maximum tolerated dose of bevacizumab when administered concurrently with metronomic doxorubicin and radiation therapy for resectable intermediate and high-grade soft tissue sarcomas
Measured: 2 years
Secondary outcomes (7)
Pathologic response rate
To determine the pathologic response rate for neoadjuvant bevacizumab, metronomic doxorubicin, and radiation therapy (trimodality therapy) for resectable intermediate and high-risk soft tissue sarcoma
Measured: 2 years
gene expression signatures
To confirm gene expression signatures as biomarkers for response to trimodality therapy
Measured: 2 years
Obtain preliminary data overall survival
To obtain preliminary data regarding overall survival with trimodality therapy
Measured: 2 years
Microvessel density
To confirm microvessel density as biomarkers for response to trimodality therapy
Measured: 2 years
Obtain preliminary data regarding local control
To obtain preliminary data regarding local control with trimodality therapy
Measured: 2 years
Obtain preliminary data regarding distant control
To obtain preliminary data regarding distant control with trimodality therapy
Measured: 2 years
Obtain preliminary data disease-free survival
To obtain preliminary data regarding disease-free survival with trimodality therapy
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 posted10 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2016
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin Choy, MD, Massachusetts General Hospital
- Investigators
- Edwin Choy, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746238
- Sponsor's protocol ID
- 12-396
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2012
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Bevacizumab, Metronomic Doxorubicin and Radiation Therapy for Resectable Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01746238
- Acronym / sponsor ID
- 12-396
- Conditions
- Sarcoma
- Keywords
- soft tissue, high grade
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Dec 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.
The main purpose of this study is to test the safety, tolerability, maximum tolerated dose, and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy.
Because bevacizumab is not considered standard therapy for sarcomas, it can only be given to subjects with sarcoma who are enrolled in this research study and may only be administered under the direction of doctors who are investigators in this research study.
This study is being done because sarcomas can recur after surgical resection (surgery for removal of the tumor), radiation therapy and chemotherapy. This recurrence can occur in the same location as the original tumor or in distant sites such as the lung. Thus better treatments are needed.
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, combination of drugs, or combination of drugs with radiation. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs and radiation is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved bevacizumab with doxorubicin and radiation for your type of cancer.
Detailed description
In order to determine if patients are eligible for this study patients will undergo some screening procedures, including a medical history, physical examination, performance status, assessment of tumor, chest CT scan, blood tests, urine test, electrocardiogram and echocardiogram. Patients will also undergo blood tests and a tumor biopsy to look for markers for your particular type of cancer.
If it is determined that patients are eligible to be in the study they will need to have a central venous line (CVL), peripherally inserted central catheter (PICC), or portacath placement. Doxorubicin administration requires a central venous line, peripherally inserted central catheter (PICC) or portacath to be placed to allow continuous infusion of this drug.
Since the investigators are looking for the highest tolerable dose of the study drug, bevacizumab, that can be administered safely without severe or unmanageable side effects in participants that have sarcoma, not everyone who participates in this research study will receive the same dose of the study drug. The dose patients get will depend on the number of participants who have been enrolled in the study and how well they have tolerated their doses. The dose of doxorubicin and radiation therapy will be the same for all subjects throughout the study.
Bevacizumab will be given as an intravenous infusion (IV). The first infusion will take about 90 minutes. All other bevacizumab infusions will take either 60 or 30 minutes, if tolerated. The first infusion will be given on a Monday (excluding holidays). Patients will receive the second infusion 2 weeks later and then every 2 weeks after that for a total of 3 doses.
Doxorubicin will be given as an intravenous infusion (IV). It will be given through a port via an infusion pump about the size of a large wallet that can fit into a front-pack or "fanny-pack" around their waist. This pump will be connected to their body. The nurses in the infusion room will start the pump and disconnect it after 4 days. The first bolus infusion take will be given 1-2 hours after their first bevacizumab infusion and will take about 30 minutes. This will be followed by a continuous IV infusion of doxorubicin over 4 days. The first bolus infusion will be given on a Monday (excluding holidays) and the continuous infusion will go until Thursday. Patients will receive a second bolus infusion followed by a 4 day continuous infusion every week for 5 weeks.
Patients will begin radiation therapy after their first bevacizumab and doxorubicin infusion on Monday (excluding holidays). Radiation therapy will be delivered five days per week (Monday through Friday-excluding holidays) over a period of 6 weeks. This is done as an outpatient procedure. Each 2-week period will be considered a separate treatment cycle. Patients will be treated with radiation therapy for a maximum of 3 cycles (6 weeks).
The following tests and procedures will be done during the study during weeks 2, 4 and 6 and before surgery: a medical history, physical examination, performance status, blood tests, urine tests and assessment for any side effects. Patients will have additional CT scans of their chest and tumor before surgery. An ECG will be repeated at this time.
A surgeon will evaluate the tumor by reviewing radiologic studies before study treatment to determine if surgical removal is possible. After patients complete study treatment with radiation therapy and bevacizumab, a surgeon will repeat the evaluation of the tumor by reviewing radiologic studies to determine if surgical removal is still possible. Patients will have surgery 6-7 weeks after they finish radiation therapy.
Patients will have additional radiation therapy if the research doctor thinks that some cancer cells may have been left in their body in the area where the tumor was removed. The radiation may be given while patients are in surgery or about two weeks after the surgery. This will be determined by the surgeon and or radiation oncologist.
Patients will be in this research study for about 3 months. After the last dose of the study drug the investigators would like to keep track of their medical condition for 10 years. The investigators would like to do this by calling patients by telephone once a year to see how they are doing. Keeping in touch with them and checking their condition every year helps the investigators look at the long term effects of the research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Bevacizumab, Drug: Doxorubicin, Radiation: Radiation TherapyBevacizumab, metronomic doxorubicin and radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary soft tissue sarcoma or isolated local recurrent sarcoma without prior radiation
- Histologically intermediate- or high-grade soft tissue sarcoma
- Determined by an expert sarcoma surgeon to have resectable disease located on the upper extremity, lower extremity, trunk, retroperitoneum or pelvis
- Primary tumor must be at least 5 cm in maximal diameter or an isolated local recurrence of any size
Key exclusion criteria (12 listed)
- Metastatic disease
- Pregnant or breastfeeding
- Immunotherapy, chemotherapy, experimental therapy or radiotherapy within 4 weeks of first day of study drug dosing
- Previously received doxorubicin, any other anthracycline chemotherapy or bevacizumab
- Major surgery within 4 weeks before first day of study drug dosing
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 |
|---|---|---|
| BevacizumabAlso: AvastinIntravenous infusion, every 2 weeks, 3 doses total | Drug | Treatment Arm |
| DoxorubicinAlso: AdriamycinIntravenous infusion, bolus infusion followed by 4 day continuous infusion, every week for 5 weeks | Drug | Treatment Arm |
| Radiation TherapyAlso: XRTDaily, Monday-Friday, for 6 weeks | Radiation | Treatment Arm |
Primary outcome
Determine MTD of bevacizumab+doxorubicin+radiation
Time frame: 2 years
To determine the maximum tolerated dose of bevacizumab when administered concurrently with metronomic doxorubicin and radiation therapy for resectable intermediate and high-grade soft tissue sarcomas
7 secondary outcomes
Pathologic response rate
Time frame: 2 years
gene expression signatures
Time frame: 2 years
Obtain preliminary data overall survival
Time frame: 2 years
Microvessel density
Time frame: 2 years
Obtain preliminary data regarding local control
Time frame: 2 years
Obtain preliminary data regarding distant control
Time frame: 2 years
Obtain preliminary data disease-free survival
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 8 Sep 2026.
- 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.
Edwin Choy, 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 study testing Bevacizumab, Doxorubicin and Radiation Therapy in people with Sarcoma, 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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. 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 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.
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?
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?
Determine MTD of bevacizumab+doxorubicin+radiation (time frame: 2 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 8 Sep 2026.