Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00740597

Purpose

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.

Condition	Intervention	Phase
Sarcoma	Procedure: gene expression analysis Procedure: intensity-modulated radiation therapy Procedure: neoadjuvant therapy Procedure: polymerase chain reaction Procedure: therapeutic conventional surgery Procedure: western blotting	Phase II

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Wound complication rate [ Designated as safety issue: No ]

Secondary Outcome Measures:

Local control rate [ Designated as safety issue: No ]
Metastatic failure rate [ Designated as safety issue: No ]
Disease-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Function and general health as measured by the Musculoskeletal Tumor Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36 [ Designated as safety issue: No ]
Changes in soft tissue sarcoma (STS) gene expression as measured by microarray analyses [ Designated as safety issue: No ]
Correlation of changes in STS gene expression with pathological and clinical outcomes [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2008
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740597

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Preeyarat Kloythanomsup 800-826-4673 PKloythanomsup@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Richard D. Pezner, MD

Beckman Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	City of Hope Comprehensive Cancer Center ( Richard D. Pezner )
Study ID Numbers:	CDR0000612344, CHNMC-07216
Study First Received:	August 22, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00740597
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Histiocytoma, Malignant Fibrous
Fibrosarcoma
Histiocytoma, Benign Fibrous
Epithelioid sarcoma
Malignant mesenchymal tumor
Osteosarcoma
Alveolar soft part sarcoma
Osteogenic sarcoma
Dermatofibrosarcoma
Hemangiopericytoma

Soft tissue sarcomas
Recurrence
Dermatofibrosarcoma protuberans
Neoplasms, Connective and Soft Tissue
Histiocytoma
Chondrosarcoma
Sarcoma
Malignant fibrous histiocytoma
Sarcoma, Alveolar Soft Part
Rhabdomyosarcoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009