This study evaluates the efficacy of the new docetaxel-cisplatin-cetuximab regimen (TPEx) versus the standard platinum-5FU-cetuximab EXTREME regimen as a first-line treatment in recurrent and/or metastatic HNSCC. Half of patients will be treated by TPEx regimen, while the other half will be treated by EXTREME regimen.
The EXTREME regimen, i.e. cetuximab added to platinum (100 mg/m² every 3 weeks ) and 5FU (96h continuous infusion at 1000 mg/m²/day every 3 weeks) during 6 cycles of treatment and continued as maintenance in patients with stable disease, is currently the standard of care in first line recurrent metastatic HNSCC. From our previous experience (phase II GORTEC "TPEx" study), the TPEx regimen of 4 cycles of docetaxel-cisplatin-cetuximab followed by maintenance with cetuximab every 2 weeks seems more efficient (overall survival) compared to EXTREME regiment. Docetaxel combined with cisplatine (each administered at 75mg/m² every 3 weeks) also appeared more convenient than the standard Cisplatin-5FU-Cetuximab EXTREME regimen (4 cycles of chemotherapy instead of 6 cycles and no i.v. continuous infusion). Toxicity was manageable with G-CSF support. In addition the toxicity / efficacy profile also seems favourable as suggested by the excellent dose intensity achieved and the high rate of patients (78%) who were able to start maintenance therapy. Taking together all these considerations, the TPEx regimen might be a good substitute for EXTREME as first-line treatment in patients with recurrent metastatic HNSCC, and it is justified and necessary to perform a direct comparison in a randomized trial to further test this hypothesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
541
Institut Sainte Catherine
Avignon, France
Centre Hospitalier de la Dracénie
Draguignan, France
Centre Médical de Forcilles
Overall survival
Overall survival is defined as the time to death from any cause measured from randomization. Patients with disease progression may be treated with off protocol therapy but will be followed for overall survival evaluation.
Time frame: Until patient death or at least one year after the end of the treatment
Objective response rate
Objective response rate (complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and assessed by central imaging review) at 12 weeks. For the statistical analysis patients not evaluable (whatever the reason, including death) will be considered as failure (i.e. no CR, no PR).
Time frame: At 12 weeks
Best overall tumor response rate
Best overall tumor response rate (RECIST 1.1 criteria) during chemotherapy and maintenance: CR or PR or SD confirmed for CR or PR by a second assessment 6 weeks later
Time frame: until progression or at least one year after the end of the treatment
Progression free survival
Progression free survival (PFS): minimum time from randomization to progression as defined by RECIST 1.1 criteria or to death from any cause. Patients who don't have any of these events are censored at the date of last follow-up.
Time frame: until progression or death or at least one year after the end of the treatment
Time to Progression
Time to Progression (TTP): minimum time from randomization to progression as defined by RECIST 1.1 criteria. In case of death from other cause than cancer and no prior progression, the patient will be censored at the time of death. In case of death related to cancer without an accurate date of progression before death, the patient will be considered in progression at the time of death. In the event of no progression and no death, the patient will be censored at the date of last follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Férolles-Attilly, France
Clinique des Ormeaux
Le Havre, France
Centre Hospitalier de Bretagne Sud (CHBS)
Lorient, France
Centre Léon Bérard
Lyon, France
Hôpital de la Timone
Marseille, France
ICM Val d'Aurelle, Montpellier
Montpellier, France
Centre Antoine-Lacassagne
Nice, France
Val de Grace
Paris, France
...and 7 more locations
Time frame: until progression or death or at least one year after the end of the treatment
Toxicity
Toxicity (according to CTC-NCI V4): all grades
Time frame: until the end of the maintenance, an expected average of 4 months of maintenance
Compliance
Compliance: Insufficient compliance for cetuximab is defined as a patient missing more than 2 consecutive infusions of cetuximab, even if the missed infusions are due to toxicity. Insufficient compliance for chemotherapy is defined as a patient missing more than 2 consecutive infusions of chemotherapy, even if the missed infusions are due to toxicity.
Time frame: until the end of the maintenance, an expected average of 4 months of maintenance
EORTC QLQ-C30
Health related quality of life (QoL) assessed by EORTC QLQ-C30. The primary endpoint of the QoL study is the global health status/quality of-life scale of the QLQ-C30 questionnaire
Time frame: At baseline before treatment, at Week 12, Week 18 and at Week 26
EuroQol-5D
Quality-adjusted life-years (QALYs) based on Euroqol EQ-5D measurements
Time frame: At baseline before treatment, at Week 12, at Week 26 and then every 2 months.until death or at least one year after the end of the treatment
Net monetary benefit
Time frame: until death or at least one year after the end of the treatment