Search / Trial NCT00001217

Osteosarcoma Study #2: A Randomized Trial of Pre-Surgical Chemotherapy vs. Immediate Surgery and Adjuvant Chemotherapy in the Treatment of Non-Metastatic Osteosarcoma. A Pediatric Oncology Group Phase III Study

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Trial Information

Current as of December 09, 2024

Completed

Keywords

Non Metastatic Osteosarcoma Presurgical Chemotherapy

ClinConnect Summary

The study is designed to determine if the administration of multi-drug adjuvant chemotherapy for patients with primary non-metastatic osteogenic sarcoma, both prior to and after the definitive surgical procedure for their primary tumor is superior as a treatment strategy to the current approach of giving drugs only after the definitive surgical procedure has been performed. An effort will be made as well to determine if the administration of pre-definitive surgery, chemotherapy leads to an increase in the proportion of the patients suitable for a limb salvage primary surgical procedure.

Gender

ALL

Eligibility criteria

  • Must be less than or equal to 30 years of age.
  • No prior history of cancer.
  • No prior therapy-other than biopsy.
  • Informed consent according or institutional guidelines (Agreement to randomization to either presurgical chemotherapy or immediate surgery-physicians must also agree).
  • Less than or equal to 21 days since initial diagnosis and eligible to have surgery within 3 weeks of randomization.
  • Must have a high grade osteosarcoma.
  • Must not have low grade osteosarcoma, periosteal and parosteal
  • osteosarcoma, or multi-focal sclerosing of osteosarcoma.
  • Tumor must be confined to extremity or expendable and resectable bone of axial skeleton (i.e., ilium, scapula, clavicle, rib).
  • No evidence of metastases by PE, CXR, chest CT, and bone scans. (Chest CT must be normal within 2 weeks of randomization). Abnormalities on chest CT must be biopsy-negative or thoracotomy negative. Suspicious lesions on bone scan should be biopsied.
  • LDH level and surgical intent (i.e., amputation, resection, or limb replacement) must be known before patient is registered.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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