An Observational Study of Avastin (Bevacizumab) in Combination With Carboplatin/Paclitaxel in First Line in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (OTILIA)

NCT01697488 | Completed

• 1 other identifier: ML27765
• Study Type: observational
• Target: 1,090
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients \>/= 70 years.

Conditions

Peritoneal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Efficacy: Progression-free survival

  up to approximately 27 months

• Safety: Incidence of adverse events

  approximately 5 years

Secondary Outcomes (4)

• Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires

  up to approximately 27 months

• Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics

  approximately 5 years

• Treatment discontinuations/modifications

  approximately 5 years

• Treatment duration

  approximately 5 years

Study Arms (2)

Cohort

Overall sample

Subgroup

Patients aged \>/= 70 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer with indication for first-line carboplatin/paclitaxel chemotherapy in combination with Avastin. In the second study phase recruitment focusses on patients \>/= 70 years.

You may qualify if:

• Study phase 1: Patients aged \>/= 18 years
• Study phase 2: Patients aged \>/= 70 years
• Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel chemotherapy in combination with Avastin

You may not qualify if:

• Contraindications to Avastin according to Summary of Product Characteristics

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Ortenau Klinikum Offenburg; Med. Klinik II; Mammachirurgie und Gynäkologisch-Onkologische Chirurgie

Offenburg, 77652, Germany

Location

Related Publications (1)

• Sehouli J, Mustea A, Oskay-Ozcelik G, Keller M, Richter R, Tome O, Woopen H, Sommer-Joos AK, Grabowski JP, Armbrust R, Wimberger P. Bevacizumab Combined with Platinum-Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients. Cancers (Basel). 2021 Sep 22;13(19):4739. doi: 10.3390/cancers13194739.

  PMID: 34638225 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: February 2, 2012
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

DE (1)