Know Cancer

or
forgot password

Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma


Phase 2/Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Osteosarcoma

Thank you

Trial Information

Evaluation of Zoledronic Acid as a Single Agent and as an Adjuvant to Chemotherapy in the Management of High Grade Osteosarcoma


Inclusion Criteria:



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.

Exclusion Criteria:

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

histological response disease free interval

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Manish Agarwal, M.S(Orth)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tata Memorial Hospital

Authority:

India: Ministry of Health

Study ID:

382

NCT ID:

NCT00691236

Start Date:

May 2008

Completion Date:

August 2013

Related Keywords:

  • Osteosarcoma
  • osteosarcoma
  • zoledronic acid
  • bisphosphonates
  • adjuvant to chemotherapy
  • Osteosarcoma

Name

Location