A clinical trial to study the effect of weekly paclitaxel in advanced epithelial ovarian cancer
- Conditions
- Malignant neoplasm of unspecifiedovary,
- Registration Number
- CTRI/2010/091/000037
- Lead Sponsor
- Department of Biotechnology Ministry of Science and Technology
- Brief Summary
This study is a randomised single centre 2 arm trial in advanced ovarian cancer comparing conventional 3 weekly regime of paclitaxel and carboplatin with weekly paclitaxel and carboplpatin for primary treatment after debulking surgery.The primary objective of the study is to compare progression free survival in 2 groups
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 270
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.
a)Patients previously treated with chemotherapy or radiotherapyb)Pregnancy and lactationc)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. ·To evaluate the quantitative levels of YKL-40 levels in peripheral blood pre and post treatment. & investigate the prognostic value of this marker.·To evaluate the quantitative levels of VEGF levels in peripheral blood pre and post treatment and correlate its levels with survival. Basline and post 6 cycles
- Secondary Outcome Measures
Name Time Method ·To compare response rates and overall survival between the two groups·To compare toxicity to chemotherapy in both groups.·To compare Quality of life in both groups Baseline and post 6 cycles
Trial Locations
- Locations (1)
Room No 245,
🇮🇳Delhi, DELHI, India
Room No 245,🇮🇳Delhi, DELHI, IndiaDr Lalit KumarPrincipal investigator01126593405stemcellaiims@yahoo.co.in