CompARE: Escalating Treatment of Intermediate and High-risk Oropharyngeal Cancer (OPC)

Sponsor
University of Birmingham
Study ID
NCT04116047
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
  • Durvalumab — DRUG
  • Radiotherapy — PROCEDURE

Study Details

CompARE is a multicentre, phase III open-label randomised controlled trial using an adaptive, Multi-Arm, Multi-Stage (MAMS) design.

Key Dates

Start date
Jul 31, 2015
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
785 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1 (control): chemoradiotherapy
    Concomitant chemoradiotherapy, 3-weekly cisplatin 100mg/m2 or weekly 40mg/m2 with Intensity Modulated Radiotherapy (IMRT) using 70 gray (Gy) in 35F(fractions) +/- neck dissection as indicated by clinical and radiological assessment 3-months post treatment. This is the international gold standard.
  • Experimental: Arm 5: Durvalumab + Arm 1
    One dose of induction durvalumab 1500mg by intravenous (IV) infusion followed by arm 1 within four weeks. Within one-two weeks after the completion of arm 1, durvalumab 1500mg every four weeks will be initiated for a total of 6 months

Primary Outcome Measure

Patient Overall survival (OS) [ Time Frame: from randomisation until date of death from any cause (follow-up until 8 years post-treatment) ]

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