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Clinical Outcomes and Treatment Compliance in Osteosarcoma Cases Treated With Low Cost Protocol in a Tertiary Care Cancer Center in India.

Outcomes, Prognostic Factors and Treatment Compliance in Osteosarcoma Cases Treated with indigenous low-cost protocol OGS-12 in a Tertiary Care Cancer Centre in India. - OGS-12

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/059247
Enrollment
543
Registered
2023-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C419- Malignant neoplasm of bone and articular cartilage, unspecified

Interventions

Intervention1: NIL: NIL Intervention2: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histologically confirmed diagnosis of osteosarcoma Age more than and equal to 15 years Extremity location Treatment naïve

Exclusion criteria

Exclusion criteria: Prior inadvertent treatment Non-osteosarcoma histology Non-extremity osteosarcomas

Design outcomes

Primary

MeasureTime frame
To evaluate the survival following treatment with surgery and OGS-12 chemotherapy protocol in newly diagnosed, treatment naïve, extremity osteosarcoma patients. The following survival endpoints will be considered: event-free survival (DFS, as the primary endpoint), and overall survival (OS, as the secondary endpoint). To evaluate fertility outcomes, long-term complications, and occupational rehabilitation among treated patients according to the following: 1. Age at menarche 2. Resumption of menarche 3. Semen/oocyte cryopreservation 4. Marriage 5. Live births 6. Long-term complications 7. Schooling 8. Jobs Timepoint: from 01/01/2017 to 31/01/2021

Secondary

MeasureTime frame
1) To evaluate the prognostic impact (in terms of EFS, OS) according to: a.Histological response b.Baseline nutritional parameters (hemoglobin, serum alkaline phosphatase, albumin) c.Treatment duration 2) To evaluate toxicities associated with OGS-12 chemotherapy protocol 3) To evaluate treatment compliance a.Incidence of treatment abandonment b.Reason for treatment abandonment c.Time from 1st chemotherapy cycle to 8th chemotherapy cycle (dose intensity)Timepoint: from 01/01/2017 to 31/01/2021

Countries

India

Contacts

Public ContactDr. Laboni Sarkar

Tata Memorial Centre Mumbai

drjyotibajpai25@gmail.com9920640040

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026