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Status:

COMPLETED

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

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Sarcoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

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. ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2006

    Estimated Enrollment :

    370 Patients enrolled

    Trial Details

    Trial ID

    NCT00091351

    Start Date

    August 1 2004

    End Date

    February 1 2006

    Last Update

    July 6 2016

    Active Locations (59)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 15 (59 locations)

    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 D.C., District of Columbia, United States, 20037