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BELOVA Data Collection: Safety and Efficacy of Frontline Bevacizumab Treatment in Participants With Ovarian Cancer 70 Years and Older

NCT02393898CompletedOBSERVATIONAL

Summary

The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).

Key Facts

Lead Sponsor

Hoffmann-La Roche

Enrollment

Start Date

2015-04-23

Completion Date

2019-06-14

Study Type

OBSERVATIONAL

Official Title

BELOVA: A Non-Interventional Study to Collect Data on the Safety and Efficacy of Frontline Bevacizumab Treatment in Ovarian Cancer Patients 70 Years and Older

Interventions

BevacizumabCarboplatinPaclitaxel

Conditions

Ovarian Cancer

Eligibility

Age Range

70 Years+

Sex

FEMALE

Inclusion Criteria:

* Aged 70 years and older
* No treatment with any other investigational agent within 28 days or 2 half-lives (whichever is longer) prior to enrollment

Exclusion Criteria:

* Contraindications, warnings, and precautions for bevacizumab

Outcome Measures

Primary Outcomes

Percentage of Participants with Adverse Events

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)

Time to First Incidence of Adverse Events of Special Interest

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months)

Secondary Outcomes

Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST)

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)

Percentage of Participants with Complete or Partial Response According to RECIST

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)

Overall Survival

Time frame: Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall)

Comprehensive Geriatric Assessment Subscale Scores

Time frame: Baseline, end of chemotherapy (up to 18 weeks), and after 10 and 15 months of bevacizumab treatment or at disease progression (up to 15 months overall)

Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg)

Time frame: Every 3 weeks according to SmPC for up to 15 months

Total Number of Bevacizumab Doses

Time frame: Every 3 weeks according to SmPC for up to 15 months

Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab

Time frame: Every 3 weeks per routine clinical practice for up to 18 weeks

Locations

Onze Lieve Vrouwziekenhuis Aalst, Aalst, Belgium

AZ Sint Lucas Brugge, Assebroek, Belgium

Imeldaziekenhuis, Bonheiden, Belgium

AZ KLINA, Brasschaat, Belgium

AZ Sint Jan, Bruges, Belgium

CHU St Pierre (St Pierre), Brussels, Belgium

Cliniques Uni Ires Saint-Luc; Gynaecology, Brussels, Belgium

GHdC Site Notre Dame, Charleroi, Belgium

UZ Antwerpen, Edegem, Belgium

ZOL (Sint Jan), Genk, Belgium

AZ Maria Middelares, Ghent, Belgium

AZ Sint Lucas (Sint Lucas), Ghent, Belgium

UZ Gent, Ghent, Belgium

CH Jolimont - Lobbes (Jolimont), Haine-Saint-Paul, Belgium

Jessa Zkh (Campus Virga Jesse), Hasselt, Belgium

AZ Groeninge, Kortrijk, Belgium

UZ Leuven Gasthuisberg, Leuven, Belgium

Chr de La Citadelle, Liège, Belgium

CHU Sart-Tilman, Liège, Belgium

Clinique Saint-Joseph, Liège, Belgium

Clinique Ste-Elisabeth, Namur, Belgium

AZ Damiaan, Ostend, Belgium

AZ Nikolaas (Sint Niklaas), Sint-Niklaas, Belgium

AZ Turnhout Sint Elisabeth, Turnhout, Belgium

CHR de Verviers - East Belgium, Verviers, Belgium

Sint Augustinus Wilrijk, Wilrijk, Belgium

Linked Papers

2022-06-06

Prospective non-interventional BELOVA/BGOG-ov16 study on safety of frontline bevacizumab in elderly patients with FIGO stage IV ovarian cancer: a study of the Belgian and Luxembourg Gynaecological Oncology Group

Because elderly patients with ovarian cancer are underrepresented in randomized studies, this study aimed to expand our knowledge on the safety and effectiveness of frontline treatment with bevacizumab in combination with standard carboplatin and paclitaxel chemotherapy in patients aged 70 years and older with a diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage IV ovarian cancer in routine clinical practice in Belgium. Patients aged 70 years and older with FIGO stage IV ovarian cancer were included in a multicenter, non-interventional prospective studyto evaluate the safety and effectiveness of treatment with bevacizumab in combination with frontline carboplatin and paclitaxel chemotherapy. Comprehensive geriatric assessments were performed at baseline and during treatment. The most frequently reported adverse events for bevacizumab were hypertension (55%), epistaxis (32%) and proteinuria (21%). The Kaplan-Meier estimate of progression-free survival was 14.5 months. The results of the comprehensive geriatric assessments during treatment indicated a slight improvement in the geriatric eight health status screening tool score for general health status and the mini-nutritional assessment score for nutritional status. The median change from baseline score was close to zero for the instruments measuring independency, activity of daily living and instrumental activities of daily living, and for the mobility-tiredness test measuring self-perceived fatigue. No new safety signals were registered in this study in patients aged 70 years and older treated with bevacizumab and frontline carboplatin and paclitaxel for FIGO stage IV ovarian cancer. Elderly patients should not be excluded from treatment for advanced ovarian cancer based on age alone. ENCEPP/SDPP/13849. NCT02393898.

Linked Investigators

Ignace Vergote