A trial to study the efficacy of metronomic chemotherapy in patients of Relapsed Ovarian Cancer.
- Conditions
- Health Condition 1: null- Relapsed Epithelial Ovarian Cancer
- Registration Number
- CTRI/2016/01/006558
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
i.Histologically or cytologically confirmed epithelial ovarian carcinoma.
ii.Patients who achieved complete remission with 1st-line treatment and at least partial response after 2nd-line chemotherapy.
iii.Patients who have clear disease progression after 2nd CR or PR
iv.ECOG performance status 0-2.
v.Adequate renal, hepatic and hematopoeitic functions.
vi.Baseline CA-125 value >= 40 U/ml, confirmed by repeat testing at baseline (to make it consistent with the definition of serological response by Rustin criteria).
vii.Patients who give informed consent to participate in the Study and are willing to comply with the follow-up schedule
i.Any other chemotherapy in the 4 weeks prior to inclusion in this study.
ii.Participation in another research protocol at the same time.
iii.Patients with evidence of partial or complete intestinal obstruction, who will be unable to comply with an oral chemotherapy protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end-point of the study was serological (CA-125) progression-free survival defined as the date from randomization to the date of first documented serological progression by the Rustin criteria, or the date of death, whichever was earlier.Timepoint: 2 years
- Secondary Outcome Measures
Name Time Method 50% serological response rate using CA-125 by the Rustin criteriaTimepoint: 2 years; <br/ ><br>Progression-free survival defined by the RECIST criteria (date of randomization to <br/ ><br> first documented progression or death, whichever is earlier). <br/ ><br>Timepoint: 2 years;Correlation of serological response with inhibition of angiogenesis and induction of <br/ ><br> apoptosis by the regimen <br/ ><br>Timepoint: 2 years;Duration of serological response (only in patients who achieve a serological response <br/ ><br> by the Rustin criteria) defined as the duration in months from first documented <br/ ><br> serological response to serological progression. <br/ ><br>Timepoint: 2 years;Evaulation of toxicity by the NCI common toxicity criteriaTimepoint: 2 years;Overall survival â?? date of randomization to deathTimepoint: 2 years;Radiological response using the RECIST criteriaTimepoint: 2 years