A Phase III Randomized Study of Preoperative Radiation Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcomas (RPS)
conventional surgery
+ radiation therapy
Fibrosarcoma+23
+ Hemangiosarcoma
+ Leiomyosarcoma
Treatment Study
Summary
Study start date: August 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.370 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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: 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 59 locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, United StatesOpen Arkansas Cancer Research Center at University of Arkansas for Medical Sciences in Google MapsCity of Hope Comprehensive Cancer Center
Duarte, United StatesUniversity of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, United StatesGeorge Washington University Medical Center
Washington D.C., United States