Health Condition 1: C40- Malignant neoplasm of bone and articular cartilage of limbs
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: NIL: NIL
Control Intervention1: Carboplatin-based and MTX-based regimens: Carboplatin regimen (carboplatin, doxorubicin, ifosfamide) or MAP
regimen (methotrexat
Sponsors
Pediatric Oncology East and Mediterranean POEM group
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proven high-grade osteosarcoma: Patients must have a confirmed diagnosis of high-grade osteosarcoma based on histological examination. 2. Localized, resectable disease: The osteosarcoma must be localized and resectable, defined as disease that is or may become amenable to complete and potentially curative surgical resection, with no evidence of metastasis. 3. Timing of chemotherapy: Chemotherapy must commence within 30 days of completing all required clinical and metastatic workup. 4. No prior chemotherapy: Patients must not have received any previous treatment for osteosarcoma or prior chemotherapy for any other disease. 5. Organ function: Participants must have organ function within safe ranges for the chemotherapy regimens to be used in the study.
Exclusion criteria
Exclusion criteria: 1. Any evidence of metastatic disease at diagnosis. 2. Unresectable disease 3. Low-grade osteosarcoma 4. Craniofacial osteosarcoma 5. Active viral hepatitis or known human immunodeficiency virus (HIV) infection or any other uncontrolled infection. 6. Active autoimmune disease requiring immunosuppressive treatment. 7. Known congenital immunodeficiency. 8. Baseline organ dysfunctions that make it unsafe for the patient to receive chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To prospectively estimate the 5-year event-free survival (EFS) rates for patients with localized, surgically resectable osteosarcoma, who are treated using either OS99 regimen (carboplatin, doxorubicin, ifosfamide) or MAP regimen (methotrexate, doxorubicin, cisplatin) as per the standard treatment guidelines at medical centers within the POEM region.Timepoint: 4 years from the date of patient enrollment to the occurrence of any of the following events: local recurrence, metastasis, disease progression, secondary malignancy, or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate both the radiologic response rates prior to surgery & the histopathologic response rates post-surgery in patients with localized osteosarcoma treated with carboplatin-based & MTX-based regimens.Timepoint: Baseline, Week 11 prior surgery, week 11 - 12 post surgery;To describe the timeliness of surgical local control, & associated barriers, in patients with localized osteosarcoma. Also the patterns of toxicity, adverse events, feasibility of timely administration, encountered in patients treated on the two treatments regimens (carboplatin-based & MTX-based).Timepoint: Baseline, week 1 - week 10 (laboratory studies during pre-surgery chemotherapy), week 11 - week 12 (pre-surgery & post surgery), week 12 - week 29 (during neoadjuvant chemotherapy) | — |
Countries
Armenia, Egypt, India, Iraq, Israel, Jordan, Lebanon, Morocco, Pakistan, Saudi Arabia
Contacts
Public ContactRwiti Clara Biswas
TATA MEDICAL CENTER
Outcome results
None listed