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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


Phase 3
N/A
N/A
Not Enrolling
Both
Osteosarcoma

Thank you

Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

870068

NCT ID:

NCT00001217

Start Date:

May 1987

Completion Date:

December 2000

Related Keywords:

  • Osteosarcoma
  • Non-Metastatic Osteosarcoma
  • Presurgical Chemotherapy
  • Osteosarcoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892