ISRCTN41478539
Active, not recruiting
Phase 3
Phase III randomised controlled trial Comparing Alternative REgimens for escalating treatment of intermediate and high-risk oropharyngeal cancer
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Birmingham
- Enrollment
- 785
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38221636/ (added 15/01/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 28/02/2022:
- •1\. Oropharyngeal squamous cell carcinoma (OPSCC) in base of tongue and tonsil (includes bilateral tumours) and uvula, with an Multidisciplinary Team (MDT) recommendation for treatment with definitive concurrent chemoradiotherapy.
- •2\. All OPC T4 or N3 (HPV\-pos and HPV\-neg) OR All HPV–neg OPC T1\-T4, N1\-N3 or T3\-4, N0 OR HPV\-pos) OPC T1\-T4 with N2b\-N3, AND who are smokers \= 10 pack years current or previous smoking history
- •3\. Minimum life expectancy of 3 months
- •4\. Eastern Cooperative Oncology Group (ECOG) performance status 0\-1 (APPENDIX 3\)
- •5\. Body weight \>30kg
- •6\. Adequate renal function, estimated glomerular filtration rate (eGFR) \>50mL/min calculated using Cockcroft\-Gault formula (APPENDIX 4\)\*
- •7\. Adequate bone marrow function (absolute neutrophil count (ANC) \=1\.5 x 109/L, haemoglobin \=9\.0g/dL and platelets \=100 x 109/L)
- •8\. Adequate liver function i.e. serum bilirubin \=1\.5 times the upper limit of normal (ULN) ,AST (SGOT)/ ALT(SGPT) \=2\.5 x institutional upper limit of normal
- •9\. Prothrombin time (PT) \=1\.5 x ULN or International Normalised Ratio (INR) \=1\. 5
Exclusion Criteria
- •Current exclusion criteria as of 28/02/2022:
- •1\. All T1\-T2,N0 OPC (HPV\-pos or HPV\-neg)
- •2\. HPV positive patients who are:
- •T1\-T3, N0\-N2c non\-smokers
- •T1\-T3, N0\-N2c smokers with \=10 pack years or
- •T1\-T3, N0\-N2a smokers with \=10 pack years
- •3\. Unfit for chemoradiotherapy regimens
- •4\. Creatinine Clearance
- •5\. Treatment with any of the following, prior to randomisation:
- •a. Any Investigational Medicinal Products (IMP) within 30 days
Outcomes
Primary Outcomes
Not specified
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