NCT01422265
Completed
N/A
Patient Reported Symptoms in Ovarian Cancer
ConditionsOvarian Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Ovarian Cancer
- Sponsor
- Genentech, Inc.
- Enrollment
- 56
- Primary Endpoint
- Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This multicenter, observational, prospective study will include approximately 20 US-based centers, and approximately 142 patients diagnosed with epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma, whose disease has recurred > 6 months after first-line platinum-based chemotherapy (first recurrence). Patients who have completed second-line chemotherapy and are currently in observation or undergoing bevacizumab maintenance treatment will be eligible to participate in the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically documented ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma that has recurred \> 6 months after platinum-based chemotherapy
- •This must be the first recurrence of the epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube carcinoma
- •Are at least two weeks but no more than 3 months after the completion of second-line cytotoxic chemotherapy
- •Are currently under observation or being treated with bevacizumab as a second-line maintenance therapy
- •Have a valid email address and access to the internet
- •Provide voluntary written informed consent
- •Speak and read English fluently
Exclusion Criteria
- •Current participation in a blinded clinical trial for ovarian cancer treatment. (Participation in a trial involving only supportive care medicines and/or growth factors is acceptable)
- •Another primary diagnosis of cancer in a different site
Outcomes
Primary Outcomes
Change in MD Anderson Symptom Inventory-Ovarian Cancer (MDASI-OC) sub-set symptom severity score before and after disease progression
Time Frame: Up to 9 months
Secondary Outcomes
- MDASI-OC Symptom Severity Score(Up to 9 months)
- MDASI-OC Symptom Interference Score(By month 9)
- HRQoL scores(Up to 9 months)
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