CTRI/2019/11/021924
Recruiting
Phase 3
ââ?¬Å?A phase III randomised trial of metronomic maintenance with oral methotrexate and propranolol versus observation after chemotherapy in relapsed platinum sensitive high grade epithelial ovarian cancerââ?¬?.
Applied for Extramural grant0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
- Sponsor
- Applied for Extramural grant
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria
- •i.Patients with high grade epithelial ovarian cancer who relapse 6 months after primary treatment with platinum based chemotherapy and achieve complete or partial response or stable disease after re challenge with platinum based doublet .
- •ii.Performance Status \- ECOG 0\-2\.
- •iii.Screening Laboratory Values within the following limits
- •a)Absolute Neutrophil count (ANC) ââ?°Â¥1500/mm 3
- •b)Platelet Count ââ?°Â¥ 100,000/mm3
- •c)Haemoglobin ââ?°Â¥ 9gm/dl
- •d)S Creatinine ââ?°Â¤1\.5 upper limit of normal (ULN)
- •e)S Bilirubin ââ?°Â¤ 1\.5 (ULN)
- •f)Aspartate Aminotransferase (AST) and/or alanine aminotransferase (ALT) \< 2 times ULN.
Exclusion Criteria
- •Exclusion Criteria
- •i.Epithelial ovarian cancer with Mucinous or Clear cell histology
- •ii.Pre \-existing use of selective or non\- selective Ã?² blockers
- •iii.Patients with Bronchial asthma or COPD or interstitial lung disease
- •iv.Patients with congestive heart failure, sinus bradycardia (HR \<60\) or any degree heart block, or any arrythmia
- •v.Patients with left ventricular ejection fraction less than 50%
- •vi.Hypersensitivity to propranolol or methotrexate
- •vii.LFT ââ?°Â¥ twice upper limit of normal
- •viii.Those with reactive HIV, HBsAg, Anti HCV status
- •ix.Patients with active tuberculosis
Outcomes
Primary Outcomes
Not specified
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