A randomised, open-label, phase III study to check the efficacy andsafety of oral afatinib versus intravenous methotrexate inpatients with recurrent and/or metastatic head and neck squamous cellcarcinoma (Cancer) who have progressed after platinum-based therapy like cisplatin or carboplatin.
- Conditions
- Health Condition 1: null- Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma.
- Registration Number
- CTRI/2014/08/004896
- Lead Sponsor
- Boehringer Ingelheim India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 300
Histologically or cytologically confirmed squamour cell carcinoma of the roal cavity, oropharynx, hypopharynx or larynx, which has recurred/metastasised and is not amenable for salvage surgery or radiotherapy
Documented porgressive deisase based on investigator assessment according to RECIST, following receipt of cisplatin and or carboplatin based regimen administered for recurrent and or metastatic disease independent of whether patient progressed during or after platinumbased therapy.
Measurable disease according to RECIST 1.1
ECOG performance status 1 or 1 at visit 2.
• Progressive disease within three months of completion of curatively intended
treatment for locoregionally advanced HNSCC or for metastatic HNSCC.
• Primary tumour site nasopharynx (of any histology), sinuses, and/or salivary
glands
• Any other than one previous platinum-based systemic regimen given for recurrent
and/or metastatic disease. Re-challenge with the first line regimen after a
temporary break is considered a second line regimen only in case of progression
within the break.
• Prior treatment with EGFR-targeted small molecules.
• Unresolved chronic toxicity, other than hearing loss, tinnitus or dry mouth,
CTCAE grade 2 from previous anti-cancer therapy or unresolved skin toxicities
CTCAE grade 1 and/or diarrhoea CTCAE grade 1 caused by prior treatment
with EGFR targeted antibodies.
• Any past or present history of areca/betel-nut chewing or its derivatives for a
cumulative duration of more than 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) based on RECIST version 1.1Timepoint: At screening (within 21 days prior to start of treatment (Visit 2) is <br/ ><br>accepted if compliant with central imaging requirements) <br/ ><br>â?? Every 6 weeks after Visit 2 <br/ ><br>â?? Every 8 weeks after treatment week 24.
- Secondary Outcome Measures
Name Time Method Health related quality of life (HRQOL)Timepoint: Every 8 weeks while on treatment;Objective response based on RECIST version 1.1Timepoint: At screening (within 21 days prior to start of treatment (Visit 2) is <br/ ><br>accepted if compliant with central imaging requirements) <br/ ><br>â?? Every 6 weeks after Visit 2 <br/ ><br>â?? Every 8 weeks after treatment week 24.;Overall survival (OS) <br/ ><br>Timepoint: Every 4 weeks after last Follow-up visit