A clinical trial to study the effect of weekly paclitaxel in advanced epithelial ovarian cancer
Phase 3
- Conditions
- Health Condition 1: null- Epithelial Ovarian CancerHealth Condition 2: C569- Malignant neoplasm of unspecifiedovary
- Registration Number
- CTRI/2010/091/000037
- Lead Sponsor
- Department of Biotechnology Ministry of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 270
Inclusion Criteria
a)Cytology proven epithelial ovarian carcinoma, FIGO stage III-IV
b)Age 18-70 years
c)ECOG performance status 0-2
d)Adequate Haemogram
e)Adequate renal and liver function tests
f)Willing to participate in the study
Exclusion Criteria
a)Patients previously treated with chemotherapy or radiotherapy
b)Pregnancy and lactation
c)Cardiac illness (patients with ejection fraction less than 45%)
d)Pre-existing neuropathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ·To compare the progression free survival in both arms. <br>·To evaluate the quantitative levels of YKL-40 levels in peripheral blood pre and post treatment. & investigate the prognostic value of this marker.<br>·To evaluate the quantitative levels of VEGF levels in peripheral blood pre and post treatment and correlate its levels with survival. <br>Timepoint: Basline and post 6 cycles
- Secondary Outcome Measures
Name Time Method ·To compare response rates and overall survival between the two groups<br>·To compare toxicity to chemotherapy in both groups.<br>·To compare Quality of life in both groups<br>Timepoint: Baseline and post 6 cycles