Clinical trial NCT00740597: Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma
Official title: Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sarcoma
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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-08-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound Complication Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
Study officials:
affiliation: City of Hope Comprehensive Cancer Center
name: Richard D. Pezner, MD
role: PRINCIPAL_INVESTIGATOR
References: