- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02999087
Randomized Trial of Avelumab-cetuximab-radiotherapy Versus SOCs in LA SCCHN (REACH) (REACH)
A Phase III Randomized Trial of Avelumab-cetuximab-Radiotherapy Versus Standards of Care in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Lorient, France, 56322
- Centre Hospitalier Bretagne Sud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≤ 80 years
- Performance Status ECOG 0-1
- Squamous cell carcinoma, previously untreated
- Stage III, stage IVa (i.e. operable, but not operated) or IVb (non resectable)
- Oral cavity, oropharynx, hypopharynx or larynx
- Availability of pre-treatment tumour tissue sample (for p16 & PD -L1 expression, TILs and immune landscape)
- Recording of alcohol consumption and smoking history
- Determination of the patient's ability to receive cisplatin 100 mg /m2 for 3 cycles (fit / unfit)*
Written informed consent
Criteria for determining if a patient is fit for receiving high dose cisplatin:
- Calculated creatinin clearance ≥ 60 mL/min as determined by the modified. method of Cockcroft and Gault or by the EDTA method
- Absolute neutrophil count ≥1 500/μL, platelets ≥100 000/μL, hemoglobin ≥ 10 g/dL, aspartate (AST) and alanine transaminase (ALT) less than 2 times the upper limit of the normal range (ULN), total bilirubin ≤ 1.5 mg/dL, serum albumin > 35 g/L
- Peripheral neuropathy < grade 2
- No clinical hearing loss (confirmed by audiogram)
- Cardiac function compatible with hyperhydration; Left ventricular ejection fraction within the institutional normal ranges as measured by echocardiogram
Exclusion Criteria:
- Nasopharyngeal, paranasal sinuses, nasal cavity tumors or thyroid cancers
- Squamous cell carcinoma involving cervical neck nodes with unknown primary site
- Metastatic disease (stage IVc)
- Viral infection (HIV, Hepatitis B/C)
- Autoimmune disease
- Immunodeficiency or immunosuppressive therapy
- Active CNS disease
- Interstitial lung disease
- Active infection
- Any prior or current treatment for invasive head and neck cancer. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior surgical resection or RT, or use of any investigational agent
- Weight loss of > 10% during the last 4 weeks (except if renutrition with a feeding tube is planned before the onset of treatment or is ongoing)
- Concurrent treatment with any other systemic anti-cancer therapy that is not specified in the protocol
- Concomitant treatment with any drug on the prohibited medication list such as live vaccines
- History of other malignancy within the last 3 years (exception of in situ carcinoma and skin carcinomas)
- Significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial
- Known hypersensitivity reaction to study drugs
- Any social, personal, medical and/or psychological factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A Patient FIT
Lead-in phase (Day-8) : no treatment Concomitant radiotherapy phase : Radiotherapy by IMRT + cisplatin 100mg/m2 Maintenance phase : no treatment until follow-up phase |
100 mg/m² IV after hyperhydration and at a maximal rate of 1 mg/min, on days 1, 22, 43.
RT will be performed using IMRT (intensity modulated radiotherapy), with a simultaneous integrated boost (SIB) technique.
RT dose to the GTV will be 69.96
Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions).
Prophylactic dose will be 52.8
Gy in 1.6 Gy daily fractions over 6.5 weeks (33 fractions).
|
Experimental: Arm B Patient FIT
Lead-in phase (Day-8) : Cetuximab 400mg/m2 and avelumab 10mg/kg Concomitant radiotherapy phase : Radiotherapy by IMRT + cetuximab 250mg/m2 and avelumab 10mg/kg Maintenance phase : avelumab 10mg/kg every 2 weeks during 12 months |
RT will be performed using IMRT (intensity modulated radiotherapy), with a simultaneous integrated boost (SIB) technique.
RT dose to the GTV will be 69.96
Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions).
Prophylactic dose will be 52.8
Gy in 1.6 Gy daily fractions over 6.5 weeks (33 fractions).
Loading dose of 400 mg/m² IV on Day-8, followed by weekly dose of 250 mg/m² IV during the whole course of RT.
IV infusion of avelumab (10 mg/kg over 1 hour) once every 2 weeks.
Avelumab will start on Day-8 together with cetuximab and subsequently every 2 weeks during the course of RT.
Avelumab with be continued every 2 weeks for an additional 12 months following RT.
|
Experimental: Arm C Patient UNFIT
Lead-in phase (Day-8) : Cetuximab 400mg/m2 and avelumab 10mg/kg Concomitant radiotherapy phase: Radiotherapy by IMRT + cetuximab 250mg/m2 and avelumab 10mg/kg Maintenance phase : avelumab 10mg/kg every 2 weeks during 12 months |
RT will be performed using IMRT (intensity modulated radiotherapy), with a simultaneous integrated boost (SIB) technique.
RT dose to the GTV will be 69.96
Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions).
Prophylactic dose will be 52.8
Gy in 1.6 Gy daily fractions over 6.5 weeks (33 fractions).
Loading dose of 400 mg/m² IV on Day-8, followed by weekly dose of 250 mg/m² IV during the whole course of RT.
IV infusion of avelumab (10 mg/kg over 1 hour) once every 2 weeks.
Avelumab will start on Day-8 together with cetuximab and subsequently every 2 weeks during the course of RT.
Avelumab with be continued every 2 weeks for an additional 12 months following RT.
|
Active Comparator: Arm D Patient UNFIT
Lead-in phase (Day-8): Cetuximab 400mg/m2 Concomitant radiotherapy phase: Radiotherapy by IMRT + cetuximab 250mg/m2 Maintenance phase : no treatment until follow-up phase |
RT will be performed using IMRT (intensity modulated radiotherapy), with a simultaneous integrated boost (SIB) technique.
RT dose to the GTV will be 69.96
Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions).
Prophylactic dose will be 52.8
Gy in 1.6 Gy daily fractions over 6.5 weeks (33 fractions).
Loading dose of 400 mg/m² IV on Day-8, followed by weekly dose of 250 mg/m² IV during the whole course of RT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months
|
Time between randomization and the first event among progression (per modified Response Evaluation Criteria in Solid Tumors (RECIST) version v1.1) and death, whatever the cause of death.
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 74 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: From date of randomization until the date of death from any cause, assessed up to 74 months
|
From date of randomization until the date of death from any cause, assessed up to 74 months
|
Safety: acute adverse events graded by NCI CTCAE v4.03
Time Frame: From date of randomization to end of study, assessed up to 74 months
|
From date of randomization to end of study, assessed up to 74 months
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GORTEC 2017-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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