Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 469
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, radiation therapy, and surgery in treating patients who have primary or recurrent sarcoma.
详细描述
OBJECTIVES:
- Determine the overall survival of patients with primary or recurrent retroperitoneal sarcomas treated with neoadjuvant doxorubicin and ifosfamide, radiotherapy, and surgical resection.
- Assess local-regional control in patients treated with this regimen.
- Determine the disease-free survival of patients treated with this regimen.
- Determine the pathologic response in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine the complications in patients treated with this regimen.
OUTLINE: Patients receive doxorubicin IV continuously on days 1-3 and ifosfamide IV over 3 hours on days 1-4. Patients also receive filgrastim (G-CSF) beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 4 courses in the absence of unacceptable toxicity. Beginning 2-4 weeks after chemotherapy, patients undergo radiotherapy daily, 5 days a week, for 5-6 weeks. Beginning 4-7 weeks after radiotherapy, patients undergo complete surgical resection with intraoperative or postoperative radiotherapy or brachytherapy.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 24 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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
- •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%
- •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
- 另有 1 项未显示
排除标准
- 未提供