Health Condition 1: null- Epithelial Ovarian Cancer Health Condition 2: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Dose dense TC: Paclitaxel 60mg per m2 day 1 8 15 every 21 days
Carboplatin AUC6 day 1 every 21 days
Control Intervention1: 3 weekly TC: Paclitaxel 175 mg per m2 IV day 1 every 21 days
C
Sponsors
Department of Biotechnology Ministry of Science and Technology
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ·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. Timepoint: Basline and post 6 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| ·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 Timepoint: Baseline and post 6 cycles | — |
Countries
India
Contacts
Public ContactDr Lalit Kumar
Department of Medical Oncology,
Outcome results
None listed