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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00017160
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary or recurrent soft tissue sarcoma of the retroperitoneum or pelvis
* No rhabdomyosarcoma, extraosseous Ewing's sarcoma, primitive neuroectodermal tumor, osteosarcoma, chondrosarcoma, Kaposi's sarcoma, or aggressive fibromatosis
* No sarcoma that does not allow sparing of two-thirds of 1 kidney within planned irradiation field
* Radiographically measurable disease greater than 5 cm (T2) by CT scan or MRI of the abdomen and pelvis
* High-grade (grade 3/3, 3/4, 4/4) disease greater than 5 cm OR
* Moderate-grade (grade 2/3, 2/4) recurrent disease greater than 10 cm
* Eligible for gross total resection (R0 or R1)
* No prior subtotal (R2) resection
* Partial debulking OR subtotal tumor resection with residual gross disease
* Fewer than 4 equivocal pulmonary lesions each less than 3 mm in diameter by CT scan
* No multifocal disease suggestive of regional nodal involvement
* No metastases
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Zubrod 0-2
Life expectancy:
* At least 2 years
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST no greater than 3 times upper limit of normal
* Albumin at least 3.5 g/dL
Renal:
* Creatinine no greater than 1.6 mg/dL
* Two functional kidneys
Cardiovascular:
* No congestive heart failure
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart disease
* Ejection fraction at least 50%
Other:
* No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No serious medical or psychiatric illness that would preclude study entry
* No obvious bowel obstruction
* No hypersensitivity to E. coli-derived products
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Oral caloric intake at least 1,500 kCal/day
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior doxorubicin or ifosfamide
* No prior chemotherapy for sarcoma
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior abdominal or pelvic irradiation
Surgery:
* See Disease Characteristics
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00017160
Study Brief:
Protocol Section:
NCT00017160