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Spots Global Cancer Trial Database for WEE1 Inhibitor With Cisplatin and Radiotherapy: A Trial in Head and Neck Cancer

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Trial Identification

Brief Title: WEE1 Inhibitor With Cisplatin and Radiotherapy: A Trial in Head and Neck Cancer

Official Title: A Phase I Trial of WEE1 Inhibition With Chemotherapy and Radiotherapy as Adjuvant Treatment, and a Window of Opportunity Trial With Cisplatin in Patients With Head and Neck Cancer

Study ID: NCT03028766

Study Description

Brief Summary: This trial is to determine what dose of a drug called AZD1775 can safely be given in combination with cisplatin before surgery and with chemo-radiotherapy after surgery in patients with Head and Neck Cancer. The Investigators will also get some preliminary information regarding the effectiveness of this combined treatment.

Detailed Description: Patients with head and neck cancer with high-risk features are at increased risk of relapse after surgery. Surgery, often followed by cisplatin chemotherapy and radiotherapy is currently the standard treatment offered. Whilst chemo-radiotherapy improves cure rates, outcomes remain poor, and treatment has a significant impact on quality of life. Chemotherapy has yet to find a definitive role prior to surgery. There is therefore an urgent need to develop more effective treatments which improve cure rates for this patient population. The purpose of this trial is to see whether incorporating a drug called AZD1775 into the management of head and neck cancer offers the possibility of addressing these clinical issues. AZD1775 is a drug that has been shown to increase the effect of cisplatin and of radiotherapy when tested in the laboratory. The blood samples and tumour biopsies taken during the trial will be important in learning as much as possible about the effects of AZD1775 on the body and to investigate how the tumour might develop resistance to the drug. The WISTERIA trial is for patients aged between 18 and 70 years with cancer of the oral cavity, larynx and hypopharynx who are to undergo surgery. Patients recruited to Group A must have accessible tumours for re-biopsy, whilst patients recruited to Group B will be at high risk of relapse after surgery. The primary objective of this trial is to see what dose of AZD1775 can safely be given in combination with cisplatin before surgery (Group A) and with chemo-radiotherapy after surgery (Group B). The Investigators will also get some preliminary information regarding the effectiveness of this combined treatment. To find the safe and effective dose of AZD1775, different doses will be tested for each Group.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University Hospital Birmingham Nhs Foundation Trust, Birmingham, West Midlands, United Kingdom

Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom

St. James' University Hospital, Leeds Teaching Hospital NHS Trust, Leeds, , United Kingdom

The Royal Marsden Hospital, London, , United Kingdom

University College London Hospitals, London, , United Kingdom

Clatterbridge Cancer Centre, Wirral, , United Kingdom

Contact Details

Name: Hisham Mehanna

Affiliation: University of Birmingham

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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