Status:
COMPLETED
Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Centre Leon Berard
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histologically-confirmed diagnosis of non metastatic squamous-cell carcinoma of oral cavity ; oropharynx, larynx or hypopharynx.
- Macroscopically complete resection of disease.
- High-risk histological features defined as :
- Microscopically incomplete tumour resection and/or invasion of regional lymph nodes with extracapsular extension (pN+R+)
- Indication of radio-chemotherapy (at least 60 Gy of radiotherapy and at least 2 cycles of chemotherapy)
- Start of radio-chemotherapy within 8 weeks after surgery
- Performance Status (PS) ECOG \<= 2
- Adequate Blood tests, renal and liver functions in the 15 days prior inclusion defined as :
- Hemoglobin \> 9 g/dL Neutrophil count \> 1500 x 109/L Platelets \> 100 x 109/L Total bilirubin \< 1,5x upper limit of normal (ULN) SGOT and SGPT \< 2,5 x ULN Alkaline Phosphatase \< 2,5 xULN Serum creatinine \< 110 µmol/L or creatinine clearance \> 55 ml/min (estimated by Cockcroft Formula) Absence of proteinuria
- Women of childbearing age must use adequate means of contraception(oral hormon contraceptive, intrauterine contraceptive device, double barrier method of contraception).
- Mandatory affiliation with a healthy security insurance.
- Dated and signed written informed consent.
Exclusion
- Macroscopic residual tumour after resection(R2)
- Metastatic disease
- Prior treatment for Head and neck cancer with chemotherapy, radiotherapy or any cancer target therapy
- Prior or concomitant malignancies (except for basal cell skin cancer ; in situ cervical carcinoma or other malignancies with a complete response \> 5 years)
- History of heavy hypersensibility reaction to Cisplatin
- Uncontrolled pulmonary, cardiac , hepatic or renal disease.
- History of interstitial pneumopathy
- Significant cardiovascular disease :
- Congestive cardiac failure\> New York Heart Association (NYHA) Class II Myocardial infraction within 6 months prior to inclusion Unstable angina Severe cardiac arrythmia Uncontrolled hypertension while receiving appropriate medication (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic) Disorder of left ventricular function with ejection fraction \< 50% Severe cerebrovascular accident within 6 months prior to inclusion History of severe thromboembolism within 6 months prior to inclusion Cardiovascular baseline QTcB \>480 ms (Calculated with Bazett Formula) Bradycardia Electrolytic disorders
- \- Hepatic affection like : hepatitis B or C chronic advanced decompensated hepatitis hepatitic cirrhosis or newly treated chronic hepatitis or nowadays treated with immunosuppressive drugs severe auto-immune hepatitis or disease
- HIV known history
- Recent digestive symptoms with diarrhea as :
- Crohn's disease malabsorption syndrome diarrhea Grade CTC ≥ 2
- Active drug or alcohol use or dependence
- Pregnant or breast-feeding women , or no use of effective birth control methods for women of childbearing potential, , or men who don't accept to use an effective birth control methods during the study
- Impossible follow-up
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT01427478
Start Date
September 1 2011
End Date
May 1 2021
Last Update
June 1 2021
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Paul Papin
Angers, France, 49933
2
Institut Sainte-Catherine
Avignon, France, 84000
3
CHU Bordeaux - Hôpital Saint-André
Bordeaux, France, 33075
4
Polyclinique de Bordeaux Nord
Bordeaux, France, 33300