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


Phase 3
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

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


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.

Inclusion 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

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:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 5 years

Safety Issue:

No

Principal Investigator

Peter W.T. Pisters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000387803

NCT ID:

NCT00091351

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Sarcoma
  • adult alveolar soft-part sarcoma
  • adult angiosarcoma
  • adult epithelioid sarcoma
  • adult fibrosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult neurofibrosarcoma
  • adult synovial sarcoma
  • adult malignant fibrous histiocytoma
  • stage I adult soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • Sarcoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
George Washington University Medical CenterWashington, District of Columbia  20037
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
LDS HospitalSalt Lake City, Utah  84143
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Fox Chase-Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442
American Fork HospitalAmerican Fork, Utah  84003
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Brigham and Women's HospitalBoston, Massachusetts  02115
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Samaritan North Cancer Care CenterDayton, Ohio  45415
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Phoebe Cancer Center at Phoebe Putney Memorial HospitalAlbany, Georgia  31702
U.T. Cancer Institute at University of Tennessee Medical CenterKnoxville, Tennessee  37920-2911
Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia FieldsOlympia Fields, Illinois  60461