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.

Phase 2

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

• Registration Number: CTRI/2022/10/046252
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

1. Patients with metastatic disease at presentation.

2. Any prior local or systemic treatment

3. Contraindication to use study medications.

ïâ??§ 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.

ïâ??§ Celecoxib:

a) Patients with known hypersensitivity to celecoxib, aspirin, or other

NSAIDs.

b) History of IHD

c) In patients with active gastrointestinal bleeding.

ïâ??· 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year Event-free survival (EFS) rate - EFS will be measured from the date of <br/ ><br>randomization to the date of progression or death. <br/ ><br>3-year Overall Survival (OS) rate ââ?¬â?? OS will be measured from the date of <br/ ><br>randomization to the date of death.Timepoint: Event- free survival (EFS) rate - 2 year <br/ ><br>Overall Survival (OS) rate - 3 year

Secondary Outcome Measures

Name	Time	Method
ilTimepoint: Nil