A Phase III randomized trial of avelumab-cetuximab- Radiotherapy versus standards of care in locally advanced squamous cell carcinoma of the head and neck (REACH)

Conditions

Squamous cell carcinoma, previously untreated Stage III, stage IVa (operable, but not operated) or IVb (non resectable) Oral cavity, oropharynx, hypopharynx or larynx

Brief summary

PFS defined as the time between randomization and the first event among progression (per radiologico-pathological combined Head & Neck cancer assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (see Appendix) and death, whatever the cause of death

Detailed description

Overall survival, Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure by Investigator assessment (Appendix 3) and cumulative incidence of death without previous progression, Safety: Acute adverse events and laboratory abnormalities as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Incidence of delayed toxicity (e.g.; dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes);, Patient-Reported Outcomes: Health related quality of life (QL) assessed by EORTC QLQC30 and H&N35 questionnaires, Progression Free Survival 2 (PFS2) defined as the time from randomization to progression on subsequent treatment for logoregional relapse, distant metastasis or detah from any cause

Related papers

No related papers found yet.

Interventions

DRUGErbitux 5 mg/mL solution for infusion

DRUGBavencio 20 mg/mL concentrate for solution for infusion

DRUGCisplatin Accord Healthcare 1 mg/ml solution à diluer pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS defined as the time between randomization and the first event among progression (per radiologico-pathological combined Head & Neck cancer assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (see Appendix) and death, whatever the cause of death	—

Secondary

Measure	Time frame
Overall survival, Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure by Investigator assessment (Appendix 3) and cumulative incidence of death without previous progression, Safety: Acute adverse events and laboratory abnormalities as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Incidence of delayed toxicity (e.g.; dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes);, Patient-Reported Outcomes: Health related quality of life (QL) assessed by EORTC QLQC30 and H&N35 questionnaires, Progression Free Survival 2 (PFS2) defined as the time from randomization to progression on subsequent treatment for logoregional relapse, distant metastasis or detah from any cause	—

Measure

Time frame

Overall survival, Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure by Investigator assessment (Appendix 3) and cumulative incidence of death without previous progression, Safety: Acute adverse events and laboratory abnormalities as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Incidence of delayed toxicity (e.g.; dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes);, Patient-Reported Outcomes: Health related quality of life (QL) assessed by EORTC QLQC30 and H&N35 questionnaires, Progression Free Survival 2 (PFS2) defined as the time from randomization to progression on subsequent treatment for logoregional relapse, distant metastasis or detah from any cause

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Countries

France

Outcome results

None listed