Combination Chemotherapy in Treating Patients Undergoing Surgery for Newly Diagnosed High-Grade Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT00645632|
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : May 16, 2011
RATIONALE: Drugs used in chemotherapy, such as ifosfamide, methotrexate, cisplatin, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well combination chemotherapy works in treating patients undergoing surgery for newly diagnosed high-grade osteosarcoma.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: cisplatin Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: methotrexate Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Not Applicable|
- To evaluate the efficacy of a new induction regimen comprising ifosfamide in combination with high-dose methotrexate, cisplatin, and doxorubicin hydrochloride, in terms of clinical response and pathological response of the tumor, in patients with newly diagnosed high-grade osteosarcoma.
- To determine the overall survival and disease-free survival of these patients.
- To evaluate the toxicity of this regimen.
- To correlate MRI imaging of the primary tumor with histopathologic grading after treatment with this regimen.
OUTLINE: This is a multicenter study.
- Neoadjuvant chemotherapy (weeks 1-15): Patients receive ifosfamide IV over 1 hour on days 1-5 and 36-40; doxorubicin hydrochloride IV over 18 hours on days 1-3 and 36-38 and IV over 72 hours on days 71-73; high-dose methotrexate IV over 4 hours on days 22, 29, 57, 64, 92, and 99; and cisplatin IV over 4 hours on day 71.
- Surgery (week 16): Patients undergo resection of the tumor on day 106. Patients found to have unresectable disease are treated on an alternative protocol unless they have clear clinical and pathologic response to treatment.
- Adjuvant chemotherapy (weeks 18-43): Beginning 2 weeks after surgery, patients receive ifosfamide IV over 1 hour on days 120-124, 155-159, 225-229, and 260-264; doxorubicin hydrochloride IV over 18 hours on days 120-122 and 155-157 and IV over 72 hours on days 190-192; high-dose methotrexate IV over 4 hours on days 141, 148, 176, 183, 211, 218, 246, 253, 281, and 288; and cisplatin IV over 4 hours on days 190 and 289.
After completion of study therapy, patients are followed every 2 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Official Title:||Treatment of Newly Diagnosed Untreated Osteosarcoma: A Pilot Study of a New Chemotherapeutic Regimen Including Ifosfamide|
|Study Start Date :||November 1990|
|Actual Primary Completion Date :||January 1995|
|Actual Study Completion Date :||January 2008|
- Histopathologic response rate
- Clinical response rate
- Disease-free survival
- Overall survival
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): NCT00645632
|Study Chair:||Gerald S. Gilchrist, MD||Mayo Clinic|
|Principal Investigator:||Tom R Fitch, M.D.||Mayo Clinic|
|Principal Investigator:||Gerardo Colon-Otero, M.D.||Mayo Clinic Florida|