Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00017160
Recruitment Status : Withdrawn
First Posted : January 27, 2003
Last Update Posted : June 27, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
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 Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Doxorubicin and Ifosfamide, Radiotherapy, and Surgical Resection in Patients With Primary or Recurrent Retroperitoneal Sarcoma

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00017160

  Show 235 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Peter W. T. Pisters, MD M.D. Anderson Cancer Center

Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00017160     History of Changes
Other Study ID Numbers: RTOG-S-0124
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Isophosphamide mustard
Immunologic Factors
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Physiological Effects of Drugs