Ovarian Cancer Clinical Trial
Official title:
AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER
| NCT number | NCT01863693 |
| Other study ID # | ML28570 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 10, 2013 |
| Est. completion date | June 15, 2018 |
| Verified date | September 2018 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This multicenter, prospective, observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. Eligible patients will be followed for approximately 15 months.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | June 15, 2018 |
| Est. primary completion date | June 15, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients, >/= 18 years of age - Advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy - Initiating Avastin in combination with chemotherapy Exclusion Criteria: - Contraindications, warnings and precautions for use as specified in the Avastin Summary of Product Characteristics |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal United Hospital; Oncology Department | Bath | |
| United Kingdom | City Hospital | Birmingham | |
| United Kingdom | Bradford Royal Infirmary; Oncology Department | Bradford | |
| United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
| United Kingdom | Queen's Hospital; Oncology Department | Burton on Trent | |
| United Kingdom | Essex County Hospital | Colchester | |
| United Kingdom | Eastborne District General Hospital | Eastbourne | |
| United Kingdom | Wonford Hospital; Oncology Department | Exeter | |
| United Kingdom | Royal Surrey County Hospital | Guildford | |
| United Kingdom | Ipswich Hospital | Ipswich | |
| United Kingdom | Airedale General Hospital; Research Office Ward 12 | Keighley | |
| United Kingdom | St James University Hospital | Leeds | |
| United Kingdom | Royal Marsden Hospital - London | London | |
| United Kingdom | Maidstone Hospital; Kent Oncology Centre | Maidstone | |
| United Kingdom | Christie Hospital Nhs Trust; Medical Oncology | Manchester | |
| United Kingdom | The James Cook University Hospital | Middlesborough | |
| United Kingdom | Mount Vernon Hospital | Middlesex | |
| United Kingdom | St Mary's Hospital | Newport | |
| United Kingdom | City Campus; Academic Unit of Oncology | Nottingham | |
| United Kingdom | Queen Alexandra Hospital; Portsmouth Haematology & Oncology Centre, Level B | Portsmouth | |
| United Kingdom | Weston Park Hospital; Cancer Clinical Trials Centre | Sheffield | |
| United Kingdom | Southampton General Hospital | Southampton | |
| United Kingdom | City General Hospital | Stoke-on-Trent | |
| United Kingdom | The Royal Marsden Hospital | Sutton | |
| United Kingdom | Singleton Hospital; Oncology | Swansea | |
| United Kingdom | Torbay Hospital; Oncology Department | Torquay | |
| United Kingdom | Royal Cornwall Hospital | Truro | |
| United Kingdom | The Clatterbridge Cancer Centre NHS Foundation Trust | Wirral | |
| United Kingdom | New Cross Hospital; Deansley Centre | Wolverhampton | |
| United Kingdom | The York Hospital | York |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression | approximately 6 years | ||
| Primary | Safety: Incidence of adverse events | approximately 6 years | ||
| Secondary | Overall survival, defined as time from first administration of first-line therapy to documented death | approximately 6 years | ||
| Secondary | Objective response rate, defined as percentage of patients with complete or partial response according to local assessments | approximately 6 years | ||
| Secondary | Quality of life: EQ-5D/EORTC questionnaires | approximately 6 years | ||
| Secondary | Dosage/schedule/duration of Avastin therapy | approximately 6 years | ||
| Secondary | Composition of first-line chemotherapy regimens: drugs/dosage/duration | approximately 6 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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