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Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma
This study has been withdrawn prior to recruitment.
Study NCT00017160   Information provided by National Cancer Institute (NCI)
First Received: June 6, 2001   Last Updated: January 11, 2007   History of Changes

June 6, 2001
January 11, 2007
 
 
 
 
Complete list of historical versions of study NCT00017160 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma
Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma

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.

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.

Phase II
Interventional
Treatment
  • 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
  • Drug: doxorubicin
  • Drug: filgrastim
  • Drug: ifosfamide
  • Procedure: biological response modifier therapy
  • Procedure: brachytherapy
  • Procedure: chemotherapy
  • Procedure: colony-stimulating factor therapy
  • Procedure: conventional surgery
  • Procedure: cytokine therapy
  • Procedure: intraoperative radiotherapy
  • Procedure: radiation therapy
  • Procedure: surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Withdrawn
 
 
 

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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00017160
 
CDR0000068657, RTOG-S-0124
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter W. T. Pisters, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP