A Phase 2 interventional study of Bevacizumab and Radiation Therapy in Soft Tissue Sarcoma, Fibrous Histiocytoma and Liposarcoma, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Treatment
The main purpose of this study is to test the effectiveness of bevacizumab in combination with radiation therapy to see what effects (good or bad) they have on patients with soft tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab in combination with radiation for sarcomas is still under investigation.
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 1,255 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)
Drug: Bevacizumab · Radiation: Radiation Therapy · Procedure: Surgery
Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses
Also known as: Avastin
External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.
Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.
Objective Response Rate for Neoadjuvant Bevacizumab Combined With Radiation Therapy for Intermediate and High-risk Soft Tissue Sarcomas.
The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.
Time frame: 3 years
Change in Median Microvessel Density (MVD) After Bevacizumab Alone
The percentage change in median microvessel density (MVD) after Bevacizumab treatment alone
Time frame: baseline and 3 years
Average Change in Blood Flow, Blood Volume,and Permeability Surface Area
The percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.
Time frame: 3 years
Local Control Rate
The number of patients with local recurrence after a median follow-up of 24 months. Local recurrence is defined as disease progression (new cancer growth) at the primary cancer site.
Time frame: 3 years
Distant Recurrence
The number of participants with distant recurrence at the time of last follow-up. Distant recurrence is when cancer has spread (metastasized) to areas farther away from where the primary cancer site is.
Time frame: 3 years
Disease Free Survival
The median amount of time from the end of treatment until to distant recurrence. Distant recurrence is when cancer spreads to areas in the body away from the primary cancer site.
Time frame: 3 years
Subjects were recruited from the multidisciplinary sarcoma clinic, surgical oncology, radiation oncology, and medical oncology clinics at the Massachusetts General Hospital, Brigham and Women's Hospital, or Dana-Farber Cancer Institute.
| Milestone | Experimental: Bevacizumab, Radiation, and Surgery |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
The count of participants with greater than or equal to 80% pathological necrosis in the resected specimen following neoadjuvant bevacizumab and radiation.
| participants | Bevacizumab, Radiation, and Surgery |
|---|---|
| 80-89% necrosis | 2 |
| 90-99% necrosis | 4 |
| 100% necrosis | 3 |
The percentage change in median microvessel density (MVD) after Bevacizumab treatment alone
| percentage of change in MVD | Bevacizumab, Radiation, and Surgery |
|---|---|
| Change in Median Microvessel Density (MVD) After Bevacizumab Alone | 53 (28.6 to 77.4) |
The percentage reduction in blood flow, blood volume,and permeability surface area of the tumor following combination therapy as determined by perfusion CT (computerized tomography) scan. The percent change represents the combined average percent change for flow, volume, and permeability together.
| Percent Reduction | Bevacizumab, Radiation, and Surgery |
|---|---|
| Average Change in Blood Flow, Blood Volume,and Permeability Surface Area | 67 (62 to 72) |
The number of patients with local recurrence after a median follow-up of 24 months. Local recurrence is defined as disease progression (new cancer growth) at the primary cancer site.
| Participants | Bevacizumab, Radiation, and Surgery |
|---|---|
| Local Recurrence | 1 |
| No Local Recurrence | 19 |
The number of participants with distant recurrence at the time of last follow-up. Distant recurrence is when cancer has spread (metastasized) to areas farther away from where the primary cancer site is.
| Participants | Experimental: Bevacizumab, Radiation, and Surgery |
|---|---|
| Distant recurrence | 7 |
| No distant recurrence | 13 |
The median amount of time from the end of treatment until to distant recurrence. Distant recurrence is when cancer spreads to areas in the body away from the primary cancer site.
| Months | Experimental: Bevacizumab, Radiation, and Surgery |
|---|---|
| Disease Free Survival | 7 (2 to 36) |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bevacizumab, Radiation, and Surgery | 3/20 (15%) | 3/20 (15%) | 20/20 (100%) |
| Event | Bevacizumab, Radiation, and Surgery |
|---|---|
| HyponatremiaMetabolism and nutrition disorders | 1/20 |
| Thrombosis/thrombus/embolismVascular disorders | 1/20 |
| DyspneaReproductive system and breast disorders | 1/20 |
| LymphopeniaBlood and lymphatic system disorders | 1/20 |
| Event | Bevacizumab, Radiation, and Surgery |
|---|---|
| HyperglycemiaMetabolism and nutrition disorders | 13/20 |
| FatigueGeneral disorders | 11/20 |
| HemoglobinBlood and lymphatic system disorders | 10/20 |
| HypertensionCardiac disorders | 10/20 |
| NauseaGastrointestinal disorders | 8/20 |
| LymphopeniaBlood and lymphatic system disorders | 7/20 |
| Diarrhea w/o prior colostomyGastrointestinal disorders | 6/20 |
| HypophosphatemiaMetabolism and nutrition disorders | 6/20 |
| Skin-otherSkin and subcutaneous tissue disorders | 5/20 |
| InsomniaGeneral disorders | 4/20 |
| Age, Categorical(Participants) | Bevacizumab, Radiation, and Surgery |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 16 |
| >=65 years | 4 |
| Age, Continuous(years) | Bevacizumab, Radiation, and Surgery |
|---|---|
| Mean | 54 ± 13 |
| Sex: Female, Male(Participants) | Bevacizumab, Radiation, and Surgery |
|---|---|
| Female | 7 |
| Male | 13 |
| Region of Enrollment(participants) | Bevacizumab, Radiation, and Surgery |
|---|---|
| United States | 20 |
| Sarcoma Histology(Participants) | Bevacizumab, Radiation, and Surgery |
|---|---|
| Fibroblastic | 8 |
| Liposarcoma | 6 |
| Leiomyosarcoma | 4 |
| Fibroblastic Osteosarcoma | 1 |
| Not Otherwise Specified | 1 |
| Sarcoma Grade(Participants) | Bevacizumab, Radiation, and Surgery |
|---|---|
| Low | 2 |
| Intermediate | 8 |
| High | 10 |
| Median Sarcoma Size(Centimeters (cm)) | Bevacizumab, Radiation, and Surgery |
|---|---|
| Median | 8.25 (5 to 20.2) |
| Sarcoma Location(Participants) | Bevacizumab, Radiation, and Surgery |
|---|---|
| Extremity | 13 |
| Trunk | 1 |
| retroperitoneal/pelvis tumors | 6 |
The record gives a start of Jul 2006, a primary completion of Mar 2010 and a completion of Mar 2010. It does not say whether these dates are actual or estimated.
Results were first posted in May 2017, 7 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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