Sarcoma
Conditions
Keywords
recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, adult alveolar soft-part sarcoma, adult epithelioid sarcoma, adult extraskeletal chondrosarcoma, adult extraskeletal osteosarcoma, adult fibrosarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult malignant mesenchymoma, adult neurofibrosarcoma, adult rhabdomyosarcoma, dermatofibrosarcoma protuberans
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.
Interventions
GENETICgene expression analysis
GENETICpolymerase chain reaction
GENETICwestern blotting
PROCEDUREneoadjuvant therapy
PROCEDUREtherapeutic conventional surgery
RADIATIONintensity-modulated radiation therapy
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complication Rate | 1 year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | insurance would not cover treatment | 1 |
Baseline characteristics
| Characteristic | Arm 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 1 year
Population: The one patient accrued to the study stopped treatment prior to completing treatment due to insurance denial.