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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00091351

Collaborator

National Cancer Institute (NCI) (NIH)

370

Enrollment

Locations

Arms

Duration (Months)

6.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Procedure: conventional surgery Radiation: radiation therapy	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

370 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Feb 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: surgery Patients undergo surgery. 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.	Procedure: conventional surgery
Experimental: radiation + surgery 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. 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.	Procedure: conventional surgery Radiation: radiation therapy

Arm

Intervention/Treatment

Experimental: surgery

Patients undergo surgery. 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.

Procedure: conventional surgery

Experimental: radiation + surgery

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. 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.

Procedure: conventional surgery

Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

Progression-free survival at 5 years [at 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-3000
3	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado	United States	80045
4	George Washington University Medical Center	Washington	District of Columbia	United States	20037
5	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-0232
6	Phoebe Cancer Center at Phoebe Putney Memorial Hospital	Albany	Georgia	United States	31701
7	Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
8	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60507
9	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
10	Joliet Oncology Hematology Associates, Limited - West	Joliet	Illinois	United States	60435
11	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
12	Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields	Olympia Fields	Illinois	United States	60461
13	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois	United States	61801
14	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
15	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
16	Saint Anthony Memorial Health Centers	Michigan City	Indiana	United States	46360
17	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242
18	James Graham Brown Cancer Center at University of Louisville	Louisville	Kentucky	United States	40202
19	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
20	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
21	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
22	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
23	Cancer Research Center at Boston Medical Center	Boston	Massachusetts	United States	02118
24	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
25	Siteman Cancer Center at Barnes-Jewish Hospital	St Louis	Missouri	United States	63110
26	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
27	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
28	Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University	Cleveland	Ohio	United States	44106
29	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
30	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
31	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
32	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
33	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
34	Middletown Regional Hospital	Middletown	Ohio	United States	45044
35	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
36	Cleveland Clinic - Wooster	Wooster	Ohio	United States	44691
37	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
38	Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97239-3098
39	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
40	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania	United States	18015
41	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
42	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania	United States	19107-5541
43	Fox Chase-Temple Cancer Center	Philadelphia	Pennsylvania	United States	19111-2497
44	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224-1791
45	U.T. Cancer Institute at University of Tennessee Medical Center	Knoxville	Tennessee	United States	37920-6999
46	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
47	American Fork Hospital	American Fork	Utah	United States	84003
48	Cottonwood Hospital Medical Center	Murray	Utah	United States	84107
49	McKay-Dee Hospital Center	Ogden	Utah	United States	84403
50	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
51	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
52	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah	United States	84106
53	LDS Hospital	Salt Lake City	Utah	United States	84143
54	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195-6043
55	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226
56	Cross Cancer Institute at University of Alberta	Edmonton	Alberta	Canada	T6G 1Z2
57	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
58	London Regional Cancer Program at London Health Sciences Centre	London	Ontario	Canada	N6A 4L6
59	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9