Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00002641|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 8, 2014
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer Kidney Cancer Ovarian Cancer Pheochromocytoma Sarcoma||Biological: filgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: isolated perfusion Procedure: adjuvant therapy Procedure: conventional surgery Radiation: radiation therapy||Phase 3|
- Compare the local disease control, overall survival, and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and G-CSF after definitive surgery.
- Compare the toxicity and morbidity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head, or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no).
Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines.
No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive surgery. Patients with complete resection undergo radiotherapy assessment and then randomization. Patients with incomplete or marginal resection (except for central lesions) undergo re-excision and, in the absence of macroscopic disease, assessment for postoperative radiotherapy followed by randomization.
Randomization: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive no adjuvant chemotherapy or filgrastim (G-CSF). Beginning within 6 weeks after surgery, eligible patients undergo radiotherapy as outlined below.
- Arm II: Beginning within 4 weeks after surgery, patients receive high-dose doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing for 10 days. Treatment continues every 3 weeks for 5 courses. Beginning within 6 weeks after completion of chemotherapy, eligible patients undergo radiotherapy as outlined below.
- Radiotherapy: Patients with incomplete or marginal resection undergo radiotherapy 5 days a week for 6-6.6 weeks. Patients with complete microscopic resection undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1 week.
Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 3.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Official Title:||RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA|
|Study Start Date :||February 1995|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||June 2012|
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|Ages Eligible for Study:||16 Years to 69 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Histologically proven soft tissue sarcoma that is amenable to definitive surgery no more than 8 weeks after biopsy or inadequate surgery
- Alveolar soft part sarcoma
- Malignant fibrous histiocytoma
- Liposarcoma (round cell and pleomorphic)
- Miscellaneous sarcoma (including pelvic mixed mesodermal tumors)
- Malignant paraganglioma
- Neurogenic sarcoma
- Synovial sarcoma
- Unclassifiable sarcoma
- Embryonal rhabdomyosarcoma
- Ewing's sarcoma
- Kaposi's sarcoma
- Liposarcoma (myxoid and well differentiated)
- Malignant mesothelioma
- Confirmed high-grade tumor (i.e., Trojani Grade II or III)
- No metastases on staging with chest x-ray and thoracic CT scan
- No regional lymph node involvement
Locally recurrent disease allowed
- Interval of 3 months or more between definitive surgery and recurrence
- 16 to 69
- WHO 0-1
- Not specified
- WBC greater than 4,000/mm^3
- Platelet count greater than 120,000/mm^3
- No bleeding disorders
- Bilirubin no greater than 1.25 times normal
- No severe hepatic dysfunction
- Creatinine less than 1.6 mg/dL OR
- Creatinine clearance greater than 60 mL/min
- No clear history of angina
- No documented myocardial infarction
- No existing cardiac failure
- No serious infection
- No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
- Not specified
- No prior systemic chemotherapy
- Not specified
- No prior radiotherapy to affected area
- See Disease Characteristics
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 ClinicalTrials.gov identifier (NCT number): NCT00002641
|Study Chair:||Penella J. Woll, MD, PhD||Cancer Research Centre at Weston Park Hospital|
|Study Chair:||Vivien H.C. Bramwell, MB, BS, PhD, FRCP||Tom Baker Cancer Centre - Calgary|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||European Organisation for Research and Treatment of Cancer - EORTC|
|Other Study ID Numbers:||
|First Posted:||January 27, 2003 Key Record Dates|
|Last Update Posted:||August 8, 2014|
|Last Verified:||July 2002|
adult synovial sarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
adult alveolar soft-part sarcoma
adult epithelioid sarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
adult malignant mesenchymoma
localized benign pheochromocytoma
stage II uterine sarcoma
stage III uterine sarcoma
recurrent uterine sarcoma
endometrial stromal sarcoma
clear cell sarcoma of the kidney
stage II adult soft tissue sarcoma
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Male Urogenital Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue