Combination Chemotherapy in Treating Patients Undergoing Surgery for Newly Diagnosed High-Grade Osteosarcoma

NCT00645632 | Completed

• 4 other identifiers: CDR0000582263P30CA015083909101549-90
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcoma

Keywords

localized osteosarcoma

Outcome Measures

Primary Outcomes (5)

• Histopathologic response rate

• Clinical response rate

• Toxicity

• Disease-free survival

• Overall survival

Interventions

cisplatin DRUG

doxorubicin hydrochloride DRUG

ifosfamide DRUG

methotrexate DRUG

adjuvant therapy PROCEDURE

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed osteosarcoma of the extremity * High-grade (grade III or IV) disease * No low-grade disease (e.g., parosteal or periosteal osteosarcoma) * No secondary osteosarcoma (i.e., tumor occurring in a radiotherapy field designed for a prior tumor) * No Paget's disease * No known metastases PATIENT CHARACTERISTICS: * Total bilirubin \< 2 times normal * AST \< 2 times normal * Alkaline phosphatase \< 2 times normal * Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min * LVEF ≥ 45% * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other prior malignancy except retinoblastoma * Patients with familial retinoblastoma syndrome who develop osteosarcoma unrelated to radiotherapy (e.g., in a primary site in the extremities) are eligible PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy * Patients with retinoblastoma may have received radiotherapy to the orbits * At least 28 days since prior initial amputation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Sarcoma

Interventions

Cisplatin; Doxorubicin; Ifosfamide; Methotrexate; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Gerald S. Gilchrist, MD

  Mayo Clinic

  STUDY CHAIR

• Tom R Fitch, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Gerardo Colon-Otero, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 27, 2008
• Study Start: November 1, 1990
• Primary Completion: January 1, 1995
• Study Completion: January 1, 2008
• Last Updated: May 16, 2011

Record last verified: 2011-05