Ovarian Cancer, Peritoneal Neoplasms Clinical Trial
Official title:
A Non-interventional Trial With Avastin as Front-line Treatment for Ovarian Cancer
| NCT number | NCT01788995 |
| Other study ID # | ML28355 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 15, 2012 |
| Est. completion date | October 11, 2018 |
| Verified date | January 2019 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This non-interventional study will evaluate the routine use and the safety and efficacy of Avastin (bevacizumab) as first-line treatment in patients with advanced ovarian cancer (epithelial ovarian cancer, fallopian tube carcinoma, primary peritoneal carcinoma). Newly diagnosed patients who are initiated on carboplatin/paclitaxel chemotherapy in combination with Avastin will be followed for up to 15 months of treatment and 12 months of follow-up.
| Status | Completed |
| Enrollment | 63 |
| Est. completion date | October 11, 2018 |
| Est. primary completion date | October 11, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients, >/= 18 years of age - Patients with newly diagnosed advanced epithelial ovarian cancer (EOC), fallopian tube carcinoma (FTC) or primary peritoneal carcinomas (PPC) with indication for first-line carboplatin/paclitaxel chemotherapy in combination with Avastin Exclusion Criteria: - Contraindications for Avastin according to the Summary of Product Characteristics |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie | Innsbruck |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical/demographic patient characteristics at initiation of treatment | approximately 4 years | ||
| Primary | Duration of treatment | approximately 4 years | ||
| Primary | Treatment discontinuations/modifications | approximately 4 years | ||
| Secondary | Safety: Incidence of adverse events | approximately 4 years | ||
| Secondary | Progression-free survival | approximately 4 years |