OPSROC (AGO-OVAR 2.21 / ENGOT-ov 18)
Research type
Research Study
Full title
A prospective randomized Phase III trial of carboplatin/gemcitabing/bevacizumab vs caboplatin/pegylated lipsomal doxorubicin/bevacizumab in patients with platinum-sensitive recurrent ovarian cancer
IRAS ID
135455
Contact name
Rosalind Glasspool
Contact email
Sponsor organisation
NHS Greater Glasgow Health Board
Eudract number
2012-004125-24
Clinicaltrials.gov Identifier
Research summary
Ovarian cancer is the fourth most common cause of cancer-related death in women. 7011 women were diagnosed with ovarian cancer in the UK in 2010 and 4295 women died of the disease. Despite debulking surgery and chemotherapy, most women with advanced disease relapse and require further treatment. Once ovarian cancer has relapsed, it is incurable and women will often undergo repeated courses of palliative chemotherapy. This study aims to identify the optimum treatment for women with ovarian cancer that has relapsed more than 6 months from first line therapy in terms of efficacy but also toxicity and effect on quality of life.
Ovarian cancer that relapses more than 6 months after initial platinum-based chemotherapy treatment is considered platinum-sensitive and is usually treated with a platinum based regimen. Previous trials have demonstrated better survival outcomes using carboplatin in combination with paclitaxel or gemcitabine over carboplatin alone. A further study demonstrated improved progression free survival (PFS) and a favourable toxicity profile for carboplatin and pegylated liposomal doxorubicin (PLD) compared to carboplatin and paclitaxel and as a result has become one of the most commonly used regimens for women with platinum sensitive ovarian cancer. More recently the addition of bevacizumab during and continuing after carboplatin and gemcitabine has been shown to significantly increase PFS compared to carboplatin and gemcitabine alone. The combination of carboplatin/PLD and bevacizumab, with bevacizumab continuing after chemotherapy until progression, has been shown to be feasible and this study is designed to assess whether this combination, which includes the preferred cytotoxic regimen of carboplatin and PLD, is better in terms of PFS than carboplatin/gemcitabine with bevacizumab continuing until progression and also to compare overall survival, the toxicity profile and patient reported outcomes between the two regimens.The Lead Sponsor for this trial is the AGO group based in Germany.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
14/ES/1058
Date of REC Opinion
9 Oct 2014
REC opinion
Further Information Favourable Opinion