Combination Chemotherapy in Treating Patients With Sarcoma
NCT ID: NCT00662233
Last Updated: 2018-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
28 participants
INTERVENTIONAL
1991-10-31
2013-10-21
Brief Summary
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PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients with sarcoma.
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Detailed Description
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* To evaluate the efficacy, in terms of clinical response, pathologic response, and long-term disease-free survival, of a multidrug chemotherapy regimen patients with spindle cell or small round cell sarcoma.
OUTLINE: This is a multicenter study.
* Induction therapy: Patients receive vincristine IV, cyclophosphamide IV over 1 hour and doxorubicin hydrochloride IV over 48 hours on day 1 in week 0. Patients continue to receive vincristine IV once weekly in weeks 1 and 2. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 3. Treatment repeats every 6 weeks for 2 courses.
* Local control: After completing induction therapy, patients are reevaluated for local control therapy. Some patients may undergo surgery and/or radiotherapy (e.g., brachytherapy, intraoperative radiotherapy, external beam therapy). Patients who undergo surgery begin consolidation therapy 2 weeks after completing surgery. Some patients undergo radiotherapy 5 days a week for 5½ weeks beginning at week 12 and/or after surgery (weeks 15-16).
* Consolidation therapy: Patients receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in weeks 12 and 18\*. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 15. Patients are reevaluated for local control therapy at week 21.
NOTE: \*Patients undergoing radiotherapy do not receive doxorubicin hydrochloride in week 18 or week 24.
* Maintenance therapy: Patient receive vincristine IV, doxorubicin hydrochloride IV over 1 hour, and cyclophosphamide IV over 1 hour once in week 24. Patients also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 21. Treatment repeats every 6 weeks for 3 courses. In week 36, patients receive vincristine, doxorubicin hydrochloride and cyclophosphamide OR etoposide and ifosfamide as before. In week 39 patients receive etoposide and ifosfamide as before.
After completion of treatment, patients are followed periodically for at least 5 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Interventions
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cyclophosphamide
doxorubicin hydrochloride
etoposide
ifosfamide
vincristine sulfate
adjuvant therapy
neoadjuvant therapy
therapeutic conventional surgery
brachytherapy
intraoperative radiation therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Carola A. S. Arndt, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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919110
Identifier Type: OTHER
Identifier Source: secondary_id
542-91
Identifier Type: OTHER
Identifier Source: secondary_id
0791
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000582271
Identifier Type: -
Identifier Source: org_study_id
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