Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	ACOSOG-Z9031 ECOG-Z9031, NCT00091351

Special Category: CTSU trial, NCI Web site featured trial

Objectives

Primary

1. 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

1. Compare the toxicity and complications associated with these regimens in these patients.
2. Compare the rate of microscopically complete surgical resection in patients treated with these regimens.
3. Compare the overall survival rate of patients treated with these regimens.

Entry Criteria

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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No concurrent chemotherapy for primary tumor

Endocrine therapy

• Not specified

Radiotherapy

• No prior abdominal or pelvic irradiation
• No concurrent intraoperative or postoperative radiotherapy for primary tumor

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

  OR

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 2,500/mm³
• Platelet count ≥ 80,000/mm³

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

Expected Enrollment

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

Outcomes

Progression-free survival at 5 years

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.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Peter Pisters, MD, Protocol chair		Ph: 713-745-3756
Brian O'Sullivan, MD, Protocol co-chair		Ph: 416-946-2125

Related Information

Featured trial web site ¹

Registry Information
Official Title		A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients with Retroperitoneal Sarcomas (RPS)
Trial Start Date		2004-08-23
Trial Completion Date		2006-02-27
Registered in ClinicalTrials.gov		NCT00091351 2
Date Submitted to PDQ		2004-08-09
Information Last Verified		2006-02-23
NCI Grant/Contract Number		CA76001

Table of Links

1	http://www.cancer.gov/clinicaltrials/ft-ACOSOG-Z9031
2	http://clinicaltrials.gov/ct/show/NCT00091351