Investigate the effect of Propranolol and Celecoxib combine with Receptor activator of nuclear factor kappa-Ã?â?? ligand (RANKL) blockade therapy during the perioperative period of Osteosarcoma (Bone cancer) patients.

Targeting perioperative period in Osteosarcoma by use of Propranolol and Celecoxib with Receptor activator of nuclear factor kappa-Ã?â?? ligand (RANKL) blockade Ã¢â?¬â?? A phase II randomized controlled study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046252

Enrollment

Registered

2022-10-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Perioperative therapy and Denosumab with OGS-12 protocol chemotherapy: The regimen comprises of oral tablet propranolol 20 mg BD for first 10 days followed by 40 mg BD thereafter and Ta

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 12 years 2. Histologically diagnosed, treatment naive, non-metastatic osteosarcoma patients planned for curative intent treatment. 3. Duration from biopsy to starting of chemotherapy less than or equal to one month. 4. Have consented to undergo perioperative treatment (propranolol and celecoxib with denosumab) after adequate staging workup.

Exclusion criteria

Exclusion criteria: 1. Patients with metastatic disease at presentation. 2. Any prior local or systemic treatment 3. Contraindication to use study medications. Ã¯â??Â§ Propranolol: a) Cardiogenic shock; b) Sinus bradycardia and greater than first-degree block; c) Bronchial asthma; and d) In patients with known hypersensitivity to Propranolol hydrochloride. Ã¯â??Â§ Celecoxib: a) Patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs. b) History of IHD c) In patients with active gastrointestinal bleeding. Ã¯â??Â· Denosumab a) Severe uncorrected hypocalcemia b) prior history of osteonecrosis or osteomyelitis of the jaw, an active dental or jaw condition requiring oral surgery, non-healed dental/oral surgery, or any planned invasive dental procedure

Design outcomes

Primary

Measure	Time frame
2-year Event-free survival (EFS) rate - EFS will be measured from the date of randomization to the date of progression or death. 3-year Overall Survival (OS) rate Ã¢â?¬â?? OS will be measured from the date of randomization to the date of death.Timepoint: Event- free survival (EFS) rate - 2 year Overall Survival (OS) rate - 3 year	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Kunal Jobanputra

Tata Memorial Hospital

drjyotibajpai25@gmail.com9920640040

Outcome results

None listed

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