Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck (BIBW2992ORL)
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|ClinicalTrials.gov Identifier: NCT01427478|
Recruitment Status : Active, not recruiting
First Posted : September 1, 2011
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Squamous Cell Carcinoma||Drug: AFATINIB Drug: Placebo of AFATINIB||Phase 3|
The reference treatment for operated squamous cell carcinoma of the head and the neck is a radiochemotherapy with Cisplatin (in the dose of intravenous 100 mg / m2 IV) every 3 weeks).
The Receptor of EGFR (Epidermal Growth Factor) or REGF is a membrane receptor; it's activation leads the cellular growth and inhibits apoptotic capacities. This receptor is overexpressed in numerous solid tumors, including ENT tumors. Several clinical studies showed that an over expression of the REGF in ENT tumors was a dominant factor of poor prognostic.
Afatinib (BIBW2992) is a strong and irreversible inhibitor of the EGFR ( type 1 human epidermic growth factor receptor, also known as HER1) and of the HER2 (human epidermal growth factor receptor 2).
Currently, 3 phase III clinical studies in postoperative situation and using an anti-REGF are in progress: 2 in concomitant situation with the radiotherapy and 1 both in concomitance and in adjuvant therapy with radiotherapy.
The preliminary results of a phase II study show that Afatinib is efficient in patients with local or metastatic relapse of a squamous cell carcinoma of the sphere ENT after a first line with Cisplatin and its tolerance is correct.
These data lead us to propose in post-operative situation, in patients with a squamous cell carcinoma of the head and neck, a radiochemotherapy with Cisplatin followed by a treatment of maintenance by Afatinib or by placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy of Afatinib (BIBW2992) in Maintenance Therapy After Post- Operative Radio-chemotherapy in Squamous-cell Carcinoma of the Head and Neck: GORTEC 2010-02|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Radiotherapy combined with a chemotherapy by Cisplatin IV at the dose of 100mg/m2 every 3 weeks, followed by a maintenance therapy with BIBW 2992 for 1 year at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months
AFATINIBat the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months
Other Name: BIBW 2992
Placebo Comparator: PLACEBO
Radiotherapy associated with a chemotherapy by Cisplatin IV at the dose of 100mg/m2 every 3 weeks, followed by a maintenance therapy with placebo of BIBW 2992 for 1 year at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months
Drug: Placebo of AFATINIB
placebo of Afatinib at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months
Other Name: Placebo of BIBW 2992
- Disease Free Survival 2 years after the end of radiotherapy [ Time Frame: 2 years after the end of radiotherapy ]
- Safety profile [ Time Frame: Every 28 days during the maintenance therapy,every 2 months during 1 year after maintenance therapy; and every 3 months during the following 3 years ]Safety profile is characterized by type; frequency and seriousness of the toxicities showed by the patients and graded using CTCAE - V04
- Quality of life of patient, evaluated by questionnary [ Time Frame: Baseline; at the end of radiotherapy, at 1 and 2 years after the beginning of maintenance treatment ]Quality of life will be evaluated at baseline; at the end of radiotherapy and also at 1 and 2 years after the beginning of maintenance treatment. The EORTC's questionnaire QLQ-C30 and the additional module " Head and neck " QLQ-H&N35 will be used.
- Overall Survival (OS) [ Time Frame: Death ]OS is the time from randomization to the date of death due to any cause or date of the last news.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427478
|Principal Investigator:||Séverine RACADOT, MD||Centre Léon Bérard; Lyon|
|Principal Investigator:||Pascal POMMIER, MD||Centre Léon Bérard , Lyon|