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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
Not Enrolling

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Trial Information

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



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


- Compare the toxicity and complications associated with these regimens in these

- 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

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

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


- 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



- 18 and over

Performance status

- ECOG 0-1 OR

- Zubrod 0-1

Life expectancy

- Not specified


- WBC ≥ 2,500/mm^3

- Platelet count ≥ 80,000/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 2.5 times ULN

- Albumin normal* NOTE: *Higher levels allowed


- Creatinine normal

- BUN normal

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


- Not pregnant

- Negative pregnancy test

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

- 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


Biologic therapy

- Not specified


- No concurrent chemotherapy for primary tumor

Endocrine therapy

- Not specified


- No prior abdominal or pelvic irradiation

- No concurrent intraoperative or postoperative radiotherapy for primary tumor


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 5 years

Safety Issue:


Principal Investigator

Peter W.T. Pisters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




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



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