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Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Wound complication rate

Safety Issue:

No

Principal Investigator

Richard D. Pezner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

07216

NCT ID:

NCT00740597

Start Date:

July 2008

Completion Date:

April 2010

Related Keywords:

  • Sarcoma
  • 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
  • Sarcoma

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010