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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-07216 | |||
| CDR0000612344 | Registry Identifier | NCI PDQ |
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No patients were enrolled on the study
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation therapy and to see how well it works in treating patients undergoing surgery for stage IB, stage II, or stage III soft tissue sarcoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery > 1 month after completion of IMRT.
Tumor tissue samples are collected at baseline and at the time of surgery for correlative laboratory studies. Samples are analyzed for gene expression by RNA microarray, real-time polymerase chain reaction, and western blotting.
After completion of study treatment, patients are followed periodically for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gene expression analysis | Genetic |
| ||
| polymerase chain reaction |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Complication Rate | Major wound complications up to 4 months post surgery include: Complications requiring a secondary operation under general or regional anesthesia for wound care. Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days. | 1 year |
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DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care
The following chemotherapy-sensitive STS histologies are excluded:
No sarcomas for which surgical staging and adjuvant radiotherapy are considered standard care (e.g., uterine sarcomas, including leiomyosarcoma, malignant mixed Müllerian tumors, and endometrial stromal sarcoma)
No retroperitoneal STS
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease
No prior radiotherapy to the site of present STS
No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents
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| Name | Affiliation | Role |
|---|---|---|
| Richard D. Pezner, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| western blotting | Genetic |
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| neoadjuvant therapy | Procedure |
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| therapeutic conventional surgery | Procedure |
|
| intensity-modulated radiation therapy | Radiation |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Complication Rate | Major wound complications up to 4 months post surgery include: Complications requiring a secondary operation under general or regional anesthesia for wound care. Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days. | The one patient accrued to the study stopped treatment prior to completing treatment due to insurance denial. | Posted | 1 year |
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Only one patients was on treatment for 5 days with no adverse events to report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam. | 0 | 0 | 0 | 0 |
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Study closed 05/12/2010 (opened 7/25/2008): No patients were accrued and treated per protocol in nearly two years (2 patients were screened). The study was terminated by the IRB when the PI decided not to continue. Protocol objectives were not met.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Frankel, Ph.D. | City of Hope National Medical Center | (626)359-8111 | 65265 | pfrankel@coh.org |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D018234 | Sarcoma, Alveolar Soft Part |
| C563195 | Chondrosarcoma, Extraskeletal Myxoid |
| D005354 | Fibrosarcoma |
| D051677 | Histiocytoma, Malignant Fibrous |
| C562740 | Hemangiopericytoma, Malignant |
| C535700 | Malignant mesenchymal tumor |
| D018319 | Neurofibrosarcoma |
| D012208 | Rhabdomyosarcoma |
| D018223 | Dermatofibrosarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009379 | Neoplasms, Muscle Tissue |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D051642 | Histiocytoma |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D010524 | Peripheral Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009217 | Myosarcoma |
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| ID | Term |
|---|---|
| D020869 | Gene Expression Profiling |
| D016133 | Polymerase Chain Reaction |
| D015153 | Blotting, Western |
| D020360 | Neoadjuvant Therapy |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D021141 | Nucleic Acid Amplification Techniques |
| D004586 | Electrophoresis |
| D002623 | Chemistry Techniques, Analytical |
| D055664 | Electrochemical Techniques |
| D015151 | Immunoblotting |
| D007118 | Immunoassay |
| D007158 | Immunologic Techniques |
| D015336 | Molecular Probe Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
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