March 2014: OCTO News
The AspECT trial is submitting an application with CTAAC for an extension beyond the end of 2014. We will apply for an extension sufficient to keep the last patient recruited on follow up for 8 years, i.e. to the end of February 2017. The outcome of the application is expected this summer. In the meantime, the decision has been taken not to request reconsent for trial patients who have not yet been approached about extending follow up from 8 years to 10 years.
This study aims to determine the safety and tolerability of combining the experimental drug BKM120 and radiotherapy for the treatment of non small cell lung cancer. The study opened in April 2013 and the group of patients recruited to first BKM120 dose level completed at the end of December. The IMP was well tolerated at this dose level with no safety issues. The study is now recruiting patients to the next dose level. You can find more information on the trial aims and procedures on the BKM120 page.
This study is evaluating a new treatment combination of the experimental drug AZD8931, in combination with XELOX in patients with Oesophago-gastric adenocarcinoma. Patients are currently being screened and recruited to the dose escalation phase in order to establish the safety and tolerability of the combination and determine the maximum tolerated dose. More information can be found on the DEBIOC page.
FOXFIRE continues to recruit well across the whole of the UK, averaging 9 patients per month. We have recruited 298 patients so far and we are on course to meet our revised target recruitment this year.
We are please to announce that recruitment in FOXFIRE will continue until 31 October 2014 (rather than 30 June 2014 as you previously planned) and that we will continue patient follow-up until 31 October 2016, with the final data lock 6-9 months from the end of follow-up
The final datalock for the trial is planned for 31st March 2014. We would like to thank everyone involved in this process for their support.
The DOC-MEK trial manuscript has been accepted for publication in Annals of Oncology and publication is expected later in 2014. The trial has two patients continuing on open label AZD6244 who are continuing to derive benefit from the treatment. Close-out of the other randomising hospital sites is going well and sites are requested to contact the DOC-MEK team if they have any questions regarding site closure.
The trial team in OCTO enjoyed meeting the site principal investigators and trial teams in London at the PACMEL away day on 10 Feb 2014 and we hope everyone who attended found the day helpful. PACMEL screening and recruitment is continuing well and recruitment is scheduled to close in December 2014. Site activations in the UK currently stand at 15 of 18 approved sites opened; negotiations are proceeding to activate up to 10 sites in Germany to recruit patients to the trial.
RHYTHM-I is now open to recruitment with the first patient entering the trial in January 2014. The RHYTHM-I study is looking at hypoxia in rectal tumours. Hypoxia (or low levels of oxygen) makes cells resistant to treatment with chemotherapy and radiotherapy. Possible treatment options are available, such as using drugs that target hypoxic cells and increasing the radiotherapy dose to all, or parts of hypoxic tumours. Previous clinical trials using hypoxia targeting agents that haven’t selected patients based upon the hypoxic status of the tumour have not been successful. Techniques to reliably identify areas of hypoxia within tumours need to be developed. This will allow doctors to identify which patients may benefit from drugs that target hypoxia or changes to their radiotherapy treatment. The RHYTHM-I study involves imaging rectal tumours using a variety of imaging techniques to inform about perfusion and hypoxia as well as looking for evidence of hypoxia in gene microarray analysis. More information about the trial aims and procedures can be found on the RHYTHM-I page.