Clinical Trials Logo

Clinical Trial Summary

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). The investigators 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00957086
Study type Interventional
Source National Cancer Centre, Singapore
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 13, 2009
Completion date January 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT02113878 - Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck Phase 1
Active, not recruiting NCT03291002 - Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC Phase 1
Terminated NCT02277184 - Ficlatuzumab, Cisplatin and IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma Phase 1
Completed NCT01080066 - A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN) N/A
Completed NCT02585973 - Dose-escalating AZD1775 + Concurrent Radiation + Cisplatin for Intermediate/High Risk HNSCC Phase 1
Completed NCT01836029 - Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Phase 2
Active, not recruiting NCT03715946 - Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer Phase 2
Active, not recruiting NCT03088059 - Biomarker-based Study in R/M SCCHN Phase 2
Recruiting NCT06003231 - A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 Phase 2
Terminated NCT02438995 - Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck Phase 1
Completed NCT02242916 - State of the Art Photon Therapy Versus Particle Therapy for Recurrent Head & Neck Tumors; a Planning Study N/A
Recruiting NCT01876693 - A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy N/A
Terminated NCT02655068 - Phase III Trial of PET/CT vs. CTSurveilance for Head and Neck Cancer Phase 3
Active, not recruiting NCT03509012 - Immunotherapy in Combination With Chemoradiation in Patients With Advanced Solid Tumors Phase 1
Active, not recruiting NCT02296684 - Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma Phase 2
Active, not recruiting NCT03799744 - Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma Phase 1
Completed NCT03109158 - NC-6004 With 5-FU and Cetuximab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Phase 1/Phase 2
Recruiting NCT03485209 - Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumors Phase 2
Completed NCT01307267 - A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab Phase 1
Terminated NCT02822482 - Copanlisib in Association With Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss Phase 1/Phase 2