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OpenTrials
Completed

NCT Number: NCT01982500

Observation of Bevacizumab Plus Front-line Chemotherapy in Patients With Ovarian Cancer

Investigators propose to assess,the safety and tolerability profile (number of participants with adverse events) of bevacizumab (Avastin) when added to chemotherapy as front-line treatment of epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Crete, Dep of Medical Oncology, Heraklion, Crete, Greece

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About this study

In the last decade, clinical studies with bevacizumab (Avastin) in various tumors have shown encouraging results in terms of efficacy/safety. However there is no data generated in Greek population with regards to safety and efficacy of bevacizumab in front line Ovarian Cancer. Two prior global phase III randomized trials showed that the addition of concurrent bevacizumab to standard chemotherapy and maintenance bevacizumab significantly increased the PFS in patients with advanced ovarian cancer It would be relevant to document the real life clinical data of bevacizumab in combination with chemotherapy (paclitaxel/carboplatin) in Front Line Ovarian Cancer as prescribed by the medical oncologists in Greece.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Age ≥18 years
  • Histologically confirmed advanced stage III (suboptimally debulked >1cm of residual disease) or stage IV ovarian cancer fallopian tube carcinoma or primary peritoneal cancer following surgical debulking with the aim of maximal surgical cytoreduction
  • One or more measurable lesions (≥1cm in diameter with spiral CT scan or ≥2cm with conventional techniques) according to RECIST criteria
  • ECOG performance status ≤2
  • Adequate haematological, renal and hepatic function
  • Urine protein <2+ (dipstick)
  • Life expectancy of >12 weeks

Exclusion criteria

  • Previous front line treatment for ovarina cancer
  • Previous radiotherapy to target lesions
  • Patients with brain metastases and/or cancerous meningitis
  • Presence or history of other neoplasm except properly treated basal cell skin cancer or in situ cervical carcinoma
  • Patients participating in interventional clinical trial

Treatment and study plan

Primary outcomes

  1. Number of Participants with Adverse Events

    Time frame: Every 3 weeks up to 18 weeks

    In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks

Secondary outcomes

  1. Number of Participants with Response Rate

    Time frame: Disease evaluation at Week 3

    In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 weeks

  2. Percentage of Patients with Progression Free Survival

    Time frame: 1 year

  3. Patients Overall Survival

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Hellenic Oncology Research Group

Other

Registry information

Official study title

A Multicentre, Observational Study of Bevacizumab (Avastin) Added to Front-line Chemotherapy in Patients With Stage IIIb, IIIC or IV Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma in Routine Clinical Practice.

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Nov 13, 2013
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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