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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01982500
Other study ID # CT/12.01
Secondary ID
Status Completed
Phase N/A
First received November 3, 2013
Last updated August 8, 2017
Start date March 2012
Est. completion date July 2017

Study information

Verified date August 2017
Source Hellenic Oncology Research Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 2017
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
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 University Hospital of Crete, Dep of Medical Oncology Heraklion Crete
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

Sponsors (1)

Lead Sponsor Collaborator
Hellenic Oncology Research Group

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events In this observational study investigators are going to assess standard schedules in which administration was every 3 weeks Every 3 weeks up to 18 weeks
Secondary Number of Participants with Response Rate In this observational study investigators are going to assess standard schedules in which the disease evaluation was performed every 3 weeks Disease evaluation at Week 3
Secondary Percentage of Patients with Progression Free Survival 1 year
Secondary Patients Overall Survival 1 year
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