Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00091351
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00091351
Study Brief:
Protocol Section:
NCT00091351