Academic Journal
Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE)
| العنوان: | Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE) |
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| المؤلفون: | de la Rosa, Consuelo Nóhpal, Krell, Jonathan, Day, Emily, Clarke, Aaron, Reddi, Meena, Webber, Lee, Fiorentino, Francesca |
| المصدر: | de la Rosa , C N , Krell , J , Day , E , Clarke , A , Reddi , M , Webber , L & Fiorentino , F 2022 , ' Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE) ' , Trials , vol. 23 , no. 1 , 13 . https://doi.org/10.1186/s13063-021-05669-9 |
| سنة النشر: | 2022 |
| المجموعة: | King's College, London: Research Portal |
| مصطلحات موضوعية: | Ovarian cancer, Paclitaxel, Platinum-resistant, Randomised controlled trial, Statistical analysis plan, TAK228 |
| الوصف: | Background: Treatment for ovarian cancer includes platinum-based chemotherapy, but many women become resistant to chemotherapy, becoming platinum-resistant. Standard of care for these women is weekly paclitaxel chemotherapy, but cancers can often become paclitaxel resistant. TAK228, an investigational dual TORC1/2 inhibitor, is an oral therapy that can be added to standard treatment. The DICE trial is a phase II international multicentre, parallel-group, superiority clinical trial with 1:1, open label randomisation which has the aim of investigating the effectiveness of TAK228 plus weekly paclitaxel. The planned sample size is 124 women (62 per treatment arm) with platinum-resistant ovarian cancer. Objective: To outline the planned analyses for DICE in a statistical analysis plan (SAP) before database hard lock and the start of analysis. This ensures that bias is minimised during the analysis phase. Results: This SAP provides detailed descriptions of the analysis principles and statistical procedures for analysing primary and secondary outcomes of the trial. The primary outcome is overall progression-free survival (PFS). Secondary outcomes include progression-free survival (PFS) at 24 weeks, overall response rate (ORR), duration of response (DoR), time to progression (TTP), clinical benefit rate (CBR) at 4 months, Cancer Antigen 125 (CA125) response according to Gynaecological Cancer Intergroup (GCIG) criteria, overall survival (OS), safety and tolerability as assessed by adverse events and the quality-of-life questionnaires (EORTC QLQ-C30 and EORTC QLQ-OV28). This detailed description includes significance levels, sensitivity analyses and compliance analysis. Discussion: The DICE trial will determine whether the addition of TAK228 to weekly paclitaxel chemotherapy shows a statistically significant improvement to participant’s progression free and overall survival and that the adverse events (AEs) and quality of life (QoL) are not significantly worse than the standard treatment. The study commenced recruitment ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1186/s13063-021-05669-9 |
| الاتاحة: | https://kclpure.kcl.ac.uk/portal/en/publications/5b615832-bcd4-4ded-ad9f-742e3841f1c8 https://doi.org/10.1186/s13063-021-05669-9 http://www.scopus.com/inward/record.url?scp=85122310513&partnerID=8YFLogxK |
| Rights: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.407F8D59 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13063-021-05669-9 |
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