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Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma

Phase 2
Not Enrolling
Stage III Adult Soft Tissue Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Stage IVA Adult Soft Tissue Sarcoma, Stage IIB Adult Soft Tissue Sarcoma, Stage IIC Adult Soft Tissue Sarcoma

Thank you

Trial Information

Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma


- 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.

Inclusion Criteria


- 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



- Not specified

Performance status:

- Zubrod 0-2

Life expectancy:

- At least 2 years


- 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


- 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


Biologic therapy:

- Not specified


- No prior doxorubicin or ifosfamide

- No prior chemotherapy for sarcoma

Endocrine therapy:

- Not specified


- No prior abdominal or pelvic irradiation


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter W. T. Pisters, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Stage III Adult Soft Tissue Sarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Stage IVA Adult Soft Tissue Sarcoma
  • Stage IIB Adult Soft Tissue Sarcoma
  • Stage IIC Adult Soft Tissue Sarcoma
  • Sarcoma



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