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CompARE

Phase III randomised controlled trial Comparing Alternative Regimens for Escalating treatment of intermediate and high-risk oropharyngeal cancer

Acronym: 
CompARE

Summary and Eligibility: 
The CompARE study has been set up to investigate which treatment is most effective for patients who have higher-risk oropharyngeal cancer. The purpose of this study is to consider using additional treatments in conjunction with standard chemoradiotherapy to increase cure rates of higher-risk oropharyngeal cancer. This will  be done  by  adding  surgery  or  more  chemotherapy or higher  dose radiotherapy  to  the  standard chemoradiotherapy

If eligible for the study, patients will be randomly allocated to one of four treatment options:

1. Standard chemoradiotherapy
2. Chemotherapy plus higher dose radiotherapy
3. Surgery plus chemoradiotherapy
4. Immunotherapy plus chemoradiotherapy

General Inclusion Criteria

• Oropharyngeal squamous cell carcinoma (OPSCC) in base of tongue and tonsil and recommendation by consultant for treatment with definitive concurrent chemoradiotherapy
• Tumour staging within protocol parameters
• ECOG status between 0 and 1
• Adequate blood values
• Age 18-70 years old and able to give informed consent
• Willingness to comply with study protocol
• Females to be of non-reproductive potential or have a negative serum pregnancy test upon study entry
• No cancers in the previous 5 years, except basal cell carcinoma of skin and cervical intra-epithelial neoplasia (CIN)
• Surgically resectable disease

General Exclusion Criteria

• Tumour staging outside of protocol parameters
• Unfit for chemoradiotherapy regimens
• Inadequate blood values
• Any of the following treatments prior to study entry:

• Treatment with another Investigational Medicinal Product (IMP) 30 days prior
• Any other chemotherapy, immunotherapy or anticancer agent within 3 weeks prior
• Major surgery within 4 weeks

• History of allergic reactions to any of the medication used in the trial
• Any other uncontrolled intercurrent illness

For full inclusion and exclusion criteria please contact the InHANSE team.

Status: 
Open

Lead Centre: 
Queen Elizabeth Hospital, Birmingham

Study Coordinator: 

Annabell Allen
CompARE Trial Coordinator
Cancer Research UK Clinical Trials Unit (CRCTU)
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham B15 2TT

Tel:      +44 (0)121 414 5101
Fax:     +44 (0)121 414 8392

CRCTU Website  Email:  CompARE@trials.bham.ac.uk 



 Study Schema: