TriangleNCT00740597 · REGISTRY CONDITION SEARCH
Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2014-07-11
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care * Stage IB-III disease * Primary or locally recurrent disease * The following chemotherapy-sensitive STS histologies are excluded: * Primitive neuroectodermal tumor * Desmoplastic small round cell tumor * Synovial sarcoma * Myxoid round cell liposarcoma * Angiosarcoma * 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: * ECOG performance status 0-2 * Able to complete the self-assessment questionnaires (may use translator service) * Willing and able to undergo pre-treatment core needle biopsies * Negative pregnancy test * No known HIV positivity PRIOR CONCURRENT THERAPY: * Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease * At least 1 year since prior adjuvant chemotherapy * No prior radiotherapy to the site of present STS * No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Genetic: gene expression analysis
- Genetic: polymerase chain reaction
- Genetic: western blotting
- Procedure: neoadjuvant therapy
- Procedure: therapeutic conventional surgery
- Radiation: intensity-modulated radiation therapy
- label
- Arm 1
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Arm 1
- name
- gene expression analysis
- type
- GENETIC
- arm Group Labels
- Arm 1
- name
- polymerase chain reaction
- type
- GENETIC
- arm Group Labels
- Arm 1
- name
- western blotting
- type
- GENETIC
- arm Group Labels
- Arm 1
- name
- neoadjuvant therapy
- type
- PROCEDURE
- arm Group Labels
- Arm 1
- name
- therapeutic conventional surgery
- type
- PROCEDURE
- arm Group Labels
- Arm 1
- name
- intensity-modulated radiation therapy
- type
- RADIATION
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Wound Complication Rate
- time Frame
- 1 year
Full study description
- brief Summary
- 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.
- detailed Description
- OBJECTIVES: Primary * Estimate the wound complication rate in patients with stage IB-III soft tissue sarcoma (STS) treated with neoadjuvant intensity-modulated radiotherapy (IMRT). Secondary * Assess local control rate in patients treated with this regimen. * Assess metastatic failure rate in patients treated with this regimen. * Assess disease-free survival of patients treated with this regimen. * Assess overall survival of patients treated with this regimen. * Assess function and general health in these patients using the Musculoskeletal Tumor Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36. * Determine changes in STS gene expression after IMRT by microarray analyses. * Correlate, preliminarily, changes in STS gene expression with pathological and clinical outcomes. 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.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice