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A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-Radiotherapy in Primary Unresected Patients with Stage III, IVa, or IVb Loco-Regionally Advanced Head and Neck Squamous Cell Carcinoma

Conditions

Brain and Nervous System | Other Respiratory and Intrathoracic Organs

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

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 squamous cell carcinoma of the head and neck.


Participation Guidelines

Age:
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • Age &ge 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
  • 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 Criteria:

  • 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 (&ge 160 mm Hg systolic and/or &ge 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 &ge 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
Sponsor:
Boehringer Ingelheim Pharmaceuticals, Inc.
Dates:
02/10/2014
Last Updated:
Study HIC#:
1208010720