Phase III, Double-Blind, Placebo-Controlled Study of Post-Operative Adjuvant Concurrent Chemo-Radiotherapy With or Without Nimotuzumab for Stage III/IV Head & Neck Squamous Cell Cancer
The aim of the study is to improve the loco-regional control rate and overall survival of
locally advanced head and neck squamous carcinoma (HNSCC). We hypothesize that the addition
of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal
growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of
concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection
of their locally advanced HNSCC will confer therapeutic advantage. We have designed a phase
III randomized study that includes a placebo arm. We assume a 10% increase in 2 year
disease free survival (from 60% to 70%). To achieve statistical significance at 90% power,
we calculate the need for 355 patients per arm, assuming also a 10% dropout rate. We aim to
accomplish this study with the involvement of a multidisciplinary team of surgical,
radiation and medical oncologists actively involved in the management of HNSCC coming from
multiple institutions and spanning at least 12 different countries. For quality assurance
we will have the involvement of Singapore Clinical Research Institute who will lead the data
coordination and ensure fidelity of data collected and statistical analysis; the European
Society of Therapeutic Radiation Oncology (EQUAL-ESTRO) for radiation dose and fields and an
international independent panel of medical oncologist, radiation oncologist and
biostatistician for the Data Monitoring Committee (DMC). This committee will monitor
significant events and advise on continuation or termination of trial. Concurrent with the
randomized trial, we will be collecting bio specimens including blood, tumour and saliva,
pre-treatment and on completion of surgical resections. We hypothesize that there are
important biomarkers including clusters of genes, cancer stem cells that will predict
prognosis and treatment response. The analyses performed will be very powerful because of
the large sample size, the specimens are collected prospectively and because the statistical
analyses will be multivariate, incorporating not only treatment but biological and staging
data.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To compare the disease-free survival between patients randomized to adjuvant nimotuzumab/cisplatin/RT with the control arm
5 years
No
K C Soo, Prof
Study Chair
National Cancer Centre
Singapore: Health Sciences Authority
IHN01
NCT00957086
August 2009
June 2016
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