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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00017160
First received: June 6, 2001
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Enrollment: 0
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017160

  Show 235 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Peter W. T. Pisters, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00017160     History of Changes
Other Study ID Numbers: RTOG-S-0124, CDR0000068657
Study First Received: June 6, 2001
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Immunologic Factors
Lenograstim
Doxorubicin
Isophosphamide mustard
Ifosfamide
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 28, 2014