NCT01746238Active, not recruitingPhase 1
Bevacizumab/Doxorubicin/Radiation for Sarcoma
Phase I Trial of Bevacizumab, Metronomic Doxorubicin and Radiation Therapy for Resectable Soft Tissue Sarcoma
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 5 Dec 2012
- Start date
- Mar 2013
- Primary completion date
- May 2016
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Sarcoma
- NCT number
- NCT01746238
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 14
- From Mar 2013 to the primary completion date, May 2016
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- History of myocardial infarction, acute coronary syndromes, coronary angioplasty or coronary artery stenting within previous 6 months
Other illness
- Metastatic disease
- Uncontrolled intercurrent illness
- 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
Other
- Pregnant or breastfeeding
- Current use of therapeutic anticoagulants
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.