Evaluation of Zolendronic acid in the management of high grade osteosarcoma

Phase 2

Completed

Conditions: Health Condition 1: null- High Grade Osteosarcoma

Registration Number: CTRI/2011/091/000189

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Inclusion criteria for part 1-

1. Adult patients (between the ages of 18 to 65 years) with a recently diagnosed high grade osteosarcoma of the extremity

2. Non Metastatic at presentation. The metastases are ruled out by a CT scan of the chest and a PET scan.

3. Patients are willing and able to afford the standard chemotherapy.

Inclusion criteria for part 2-

1.Patients (between the ages of 18 to 65 years) with a high grade osteosarcoma of the extremity unable to afford or take the standard chemotherapy

2.Relapsed osteosarcoma unsuitable or unable to afford second line chemotherapy

Exclusion Criteria

Exclusion criteria for part 1-

1.Non-extremity sarcomas. (pelvis and spine)
2.Age less than 18 years or greater than 65 years
3.Metastatic at presentation
4.Pregnant or lactating women
5.Renal dysfunction in the form of elevated serum creatinine
6.Dental treatment anticipated after evaluation.
7.Patients who have received or are likely to receive steroids.

Exclusion criteria for part 2-
1.Able to take some chemotherapy or second line chemotherapy
2.Renal dysfunction in the form of elevated serum creatinine
3.Dental treatment anticipated after evaluation.
4.Unable to follow-up regularly as required by the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The histological response to chemotherapy will be used as the primary endpoint. Histological response to chemotherapy as assessed by the Huvos method. Grade 1 : 50% necrosis Grade 2: 50% but 90% necrosis Grade 3: 90% but ,100% necrosis Grade 4: 100% or complete response.Timepoint: 4 Years

Secondary Outcome Measures