Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Primary or Recurrent Sarcoma - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00017160

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 II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma Surgery

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Filgrastim Ifosfamide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

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

Show 235 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Peter W. T. Pisters, MD

M.D. Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	CDR0000068657, RTOG-S-0124
Study First Received:	June 6, 2001
Last Updated:	January 11, 2007
ClinicalTrials.gov Identifier:	NCT00017160 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Disease Attributes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Recurrence
Doxorubicin
Pharmacologic Actions

Neoplasms, Connective and Soft Tissue
Neoplasms
Ifosfamide
Pathologic Processes
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents
Isophosphamide mustard

ClinicalTrials.gov processed this record on November 27, 2009