Imperial College London
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DrJonathanKrell

Faculty of Medicine, Department of Surgery & Cancer

Clinical SL in Medical Oncology (Gynaecological Oncology)
 
 
 
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j.krell

 
 
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Location

 

Institute of Reproductive and Developmental BiologyHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Fiorentino:2022:10.1186/s13063-022-06201-3,
author = {Fiorentino, F and Krell, J and de, la Rosa CN and Webber, L},
doi = {10.1186/s13063-022-06201-3},
journal = {Trials},
pages = {1--15},
title = {DICE: Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian cancer resistant to standard treatment-a study protocol for a randomised trial investigating a novel therapy called TAK228},
url = {http://dx.doi.org/10.1186/s13063-022-06201-3},
volume = {23},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BackgroundThe standard initial treatment for ovarian cancer is surgery and platinum-based chemotherapy and potentially maintenance therapy with avastin or inhibitors of poly-ADP ribose polymerase (PARP). While a proportion of women are cured by this approach, the vast majority will relapse and become resistant to platinum chemotherapy either initially or on subsequent treatment. There is an unmet need to improve response to treatment and quality of life in these women. TAK228 is a novel therapy that can be added to standard treatment in the participant population and the aim of the DICE trial is to assess its effectiveness. Laboratory and clinical research has shown that these ovarian cancers may respond to the molecular target of a drug such as TAK228, and there have been studies using it in other advanced solid tumours including endometrial cancer.MethodsOne hundred twenty-four eligible women will be recruited from participating research sites in the United Kingdom (UK) and Germany. Randomised participants will receive either weekly paclitaxel alone (standard treatment, n = 62) or TAK228 plus weekly paclitaxel (n = 62) until the cancer significantly worsens; there are significant adverse events or any other protocol-defined stopping criteria. Participants will be monitored for response to treatment (using radiological imaging), adverse events and quality of life during both randomised treatment and subsequent follow-up.DiscussionThe primary objective/endpoint of the study is to compare the two treatments in terms of progression-free survival, or the length of time that each participant is alive without the cancer significantly worsening according to defined assessment criteria. If the addition of TAK228 to weekly paclitaxel chemotherapy is shown to significantly improve this statistically, and adverse events and quality of life are not significantly worse than standard treatment, then TAK228 plus weekly paclitaxel could potentially be taken forward within the cont
AU  - Fiorentino,F
AU  - Krell,J
AU  - de,la Rosa CN
AU  - Webber,L
DO  - 10.1186/s13063-022-06201-3
EP  - 15
PY  - 2022///
SN  - 1745-6215
SP  - 1
TI  - DICE: Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian cancer resistant to standard treatment-a study protocol for a randomised trial investigating a novel therapy called TAK228
T2  - Trials
UR  - http://dx.doi.org/10.1186/s13063-022-06201-3
UR  - https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000778488100005&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06201-3
UR  - http://hdl.handle.net/10044/1/100783
VL  - 23
ER  -
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