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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00740597
• Other study ID #: 07216
• Secondary ID: P30CA033572CHNMC
• Status: Terminated
• Phase: Phase 2
• First received: August 22, 2008
• Last updated: June 12, 2014
• Start date: July 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2014
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Genetic:
• gene expression analysis

• polymerase chain reaction

• western blotting

Procedure:
• neoadjuvant therapy

• therapeutic conventional surgery

Radiation:
• intensity-modulated radiation therapy

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year	No