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

Primary Purpose

Sarcoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gene expression analysis
polymerase chain reaction
western blotting
neoadjuvant therapy
therapeutic conventional surgery
intensity-modulated radiation therapy
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2008
Last Updated
June 12, 2014
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00740597
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
No patients were enrolled on the study
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
western blotting
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Primary Outcome Measure Information:
Title
Wound Complication Rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D. Pezner, MD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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