Maintenance Pazopanib to prevent relapse of advanced sarcomas
Phase 2
- Conditions
- Health Condition 1: C402- Malignant neoplasm of long bones of lower limb
- Registration Number
- CTRI/2021/10/037144
- Lead Sponsor
- HCG Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Histologically confirmed diagnosis of primary bone or soft tissue sarcoma (AJCC 8th edition Stage III or IV)â??
Completed standard treatment (Surgery with or without Chemotherapy and Radiotherapy)â??
Absence of metastases and local relapse after treatmentâ??
ECOG <=2â??
Adequate bone marrow function (i.e., peripheral absolute neutrophils >1,500, platelets >1,00,000)â??
Further lab parameters restricted to bilirubin <2, creatinine < 1.5x normal
Exclusion Criteria
Missing staging criteriaâ??
Last antineoplastic treatment received within 30 days prior to study entryâ??
Concomitant treatment with drugs having either immunostimulatory or immunosuppressive propertiesâ??
Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival at 6months, 12months, 18months and 24monthsTimepoint: Disease free survival at 6months, 12months, 18months and 24months
- Secondary Outcome Measures
Name Time Method Quality of lifeTimepoint: 24 months