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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hellenic Oncology Research Group Identifier:
First received: November 3, 2013
Last updated: February 22, 2017
Last verified: February 2017
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

Ovarian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
Official 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.

Resource links provided by NLM:

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • Percentage of Patients with Progression Free Survival [ Time Frame: 1 year ]
  • Patients Overall Survival [ Time Frame: 1 year ]

Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: June 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Avastin regimens
Patients who are going to receive chemotherapy plus Avastin (bevacizumab)

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Clinics for cancer prevention

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01982500

University Hospital of Crete, Dep of Medical Oncology
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupolis, Greece
"IASO" General Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
Principal Investigator: Antonia Kalykaki, MD Hellenic Oncology Research Group
  More Information

Responsible Party: Hellenic Oncology Research Group Identifier: NCT01982500     History of Changes
Other Study ID Numbers: CT/12.01
Study First Received: November 3, 2013
Last Updated: February 22, 2017

Keywords provided by Hellenic Oncology Research Group:
Ovarian Cancer
Anti-angiogenic agent
Front Line

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on May 25, 2017