![](http://192.168.10.30/wp-content/uploads/2023/02/image-1.png)
A phase 1b TiTE-CRM dose escalation clinical trial of tolinapant (ASTX660) in combination with standard radical chemoradiotherapy in cervical cancer
Trial summary:
CRAIN is a phase 1b open-label, multi-centre study to characterise the safety and tolerability and initial evidence for clinical activity of tolinapant when administered in combination with cisplatin based CRT to women with newly diagnosed cancer of the cervix. The trial primary objective is to establish the maximum tolerated safe dose of tolinapant in combination with Cisplatin & Radiotherapy (CRT) to aid dose selection for a phase II trial.
RT QA summary:
All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.
QA Process | QA Activity | Required for Trial | Additional Details |
---|---|---|---|
Pre-Accrual | Facility Questionnaire | ![]() | |
Outlining Benchmark Case | ![]() | 1 case | |
Planning Benchmark Case | ![]() | 1 case | |
Dummy Run | ![]() | 1 case (Brachytherapy) | |
During Accrual | Individual Case Review | Prospective: first patient Retrospective: all patients |
|
Data collection | |||
Dosimetry | ![]() | ||
QA Streamlining | ![]() | INTERLACE trial and EMBRACE |
RTTQA contact: newtrialsqa.enh-tr@nhs.net
Chief investigator: Professor Peter Hoskin, The Christie NHS Foundation Trust
Sponsor: University Hospital Southampton NHS Trust,sponsor@uhs.nhs.uk
Funder: Cancer Research UK Combination Alliance (Award Reference: CRCPJT\100019) with provision of tolinapant from Astex Pharmaceuticals, Inc.