Surgery With or Without Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Retroperitoneum or Pelvis

Sarcoma Clinical Trial

Official title:

A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091351
• Other study ID #: ACOSOG-Z9031
• Secondary ID: ACOSOG-Z9031CDR0
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2004
• Last updated: July 1, 2016
• Start date: August 2004
• Est. completion date: February 2006

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether surgery is more effective with or without radiation therapy.

PURPOSE: This randomized phase III trial is studying surgery alone to see how well it works compared to radiation therapy together with surgery in treating patients with primary soft tissue sarcoma of the retroperitoneum or pelvis.

Description:

OBJECTIVES:

Primary

• Compare progression-free survival of patients with primary soft tissue sarcoma of the retroperitoneum or pelvis treated with surgery with vs without preoperative radiotherapy.

Secondary

• Compare the toxicity and complications associated with these regimens in these patients.

• Compare the rate of microscopically complete surgical resection in patients treated with these regimens.

• Compare the overall survival rate of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor grade (low [G1] vs intermediate [G2] vs high [G3/4]), tumor size (< 15 cm vs ≥ 15 cm), and tumor histology (liposarcoma vs non-liposarcoma). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo surgery.

• Arm II: Patients undergo preoperative radiotherapy once daily, 5 days a week, for 5.5 weeks. Within 28-63 days after the completion of radiotherapy, patients undergo surgery.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 28 days, 4 months, every 6 months for 5 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this study within 4.5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed primary soft tissue sarcoma of the retroperitoneum or pelvis (e.g., iliac fossa)

• The following histologies are eligible:

• Alveolar soft part sarcoma

• Anaplastic sarcoma

• Angiosarcoma

• Atypical lipomatous tumor (low-grade liposarcoma)

• Clear cell sarcoma

• Epithelioid sarcoma

• Fibrosarcoma

• Leiomyosarcoma

• Liposarcoma (all subtypes)

• Malignant fibrous histiocytoma

• Malignant peripheral nerve sheath tumor

• Myxofibrosarcoma

• Neurofibrosarcoma

• Spindle cell sarcoma

• Synovial sarcoma

• Unclassified sarcoma

• The following histologies are not eligible:

• Rhabdomyosarcoma

• Extraosseous Ewing's sarcoma

• Primitive neuroectodermal tumor

• Osteosarcoma

• Chondrosarcoma

• Aggressive fibromatosis (desmoid tumor)

• Gastrointestinal stromal tumor

• Sarcomatoid carcinoma

• Hemangiopericytoma

• Retroperitoneal sarcomas located predominantly in the retroperitoneum extending across the inguinal ligament into the abdominal wall are allowed provided that = 90% of the tumor volume is located within the retroperitoneal space

• No bowel obstruction OR history of previous bowel obstruction attributed to retroperitoneal tumor

• Primary non-visceral retroperitoneal masses consistent with sarcoma allowed provided diagnoses of carcinoma, melanoma, and lymphoma are excluded by immunohistochemistry

• Measurable gross disease by abdominopelvic CT scan (with IV and oral contrast) or MRI (with IV contrast)

• Patients must have undergone radiotherapy consultation within the past 30 days to confirm the feasibility of preoperative external-beam radiotherapy

• Patients must have undergone surgical consultation within the past 30 days to confirm and document the feasibility of macroscopically complete resection

• No prior macroscopically incomplete (R2) resection (i.e., partial debulking or subtotal tumor resection with gross residual disease)

• No pelvic sarcoma extending through the sciatic notch

• No clinical or radiographic evidence of probable metastatic disease

• Equivocal pulmonary or liver lesion allowed provided the likelihood of metastatic disease is small

• No sarcoma arising from bone or any retroperitoneal viscus (except the kidney)

• No sarcoma extending across the diaphragm into the thorax

• No recurrent retroperitoneal tumor

• No multifocal disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1 OR

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC = 2,500/mm^3

• Platelet count = 80,000/mm^3

Hepatic

• Bilirubin = 1.5 times upper limit of normal (ULN)

• AST = 2.5 times ULN

• Albumin normal* NOTE: *Higher levels allowed

Renal

• Creatinine normal

• BUN normal

• Functional kidney confirmed by intravenous pyelogram and/or differential renal isotope scan

Other

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No other malignancy within the past 5 years (except effectively treated basal cell or squamous cell skin cancer) unless patient was curatively treated AND is at low risk for recurrence

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No concurrent chemotherapy for primary tumor

Radiotherapy

• No prior abdominal or pelvic irradiation

• No concurrent intraoperative or postoperative radiotherapy for primary tumor

Surgery

• See Disease Characteristics

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	Cross Cancer Institute at University of Alberta	Edmonton	Alberta
Canada	London Regional Cancer Program at London Health Sciences Centre	London	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
United States	Phoebe Cancer Center at Phoebe Putney Memorial Hospital	Albany	Georgia
United States	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	American Fork Hospital	American Fork	Utah
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University	Cleveland	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	U.T. Cancer Institute at University of Tennessee Medical Center	Knoxville	Tennessee
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Olympia Fields	Illinois
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Fox Chase-Temple Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia
United States	University Cancer Center at University of Washington Medical Center	Seattle	Washington
United States	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	George Washington University Medical Center	Washington	District of Columbia
United States	Cleveland Clinic - Wooster	Wooster	Ohio
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival at 5 years		at 5 years	No