Global Phase III Clinical Trial to Treat Head and Neck Cancer Begins

Wednesday, 16 Dec 2009

Singapore, 16 Dec 2009 – A global clinical trial led by the National Cancer Centre Singapore (NCCS) has recruited the first patient, who is suffering from squamous cell carcinoma of the head and neck.

About 300 Singaporeans are diagnosed with head and neck cancer each year, the majority of which are squamous cell carcinoma. At present, 40 per cent of such patients will survive beyond five years after surgery with chemotherapy and radiotherapy but NCCS hopes to improve the survival rate with the global phase III clinical trial.

This study hopes to determine if the use of a promising new agent called Nimotuzumab can improve the survival outcome of patients with advanced head and neck cancer who had surgery. It is well-known that some patients after surgery exhibit radiologic and/or microscopic features that predict for a higher risk of recurrence even with adjuvant radiotherapy. It is now standard practice to prescribe radiotherapy and concurrent administration of a chemotherapy agent called Cisplatin after surgery for such high risk patients as studies have shown survival benefit with this approach.

However, despite the addition of Cisplatin to radiation, the risk of relapse is still significant. This global study hopes to improve upon the results of this standard treatment.

The global phase III study follows the on-going phase II study of Nimotuzumab in combination with chemoradiotherapy in NCCS, in which 14 patients have been treated or currently on treatment. The impressions and results gathered from this study and other completed studies conducted to date have shown that Nimotuzumab is a drug with low toxicity profile.

The successful completion of the global phase III study, which involves at least 22 institutions from 12 countries worldwide, will help to determine if the addition of Nimotuzumab can enhance the survival of patients who suffer from this cancer. In addition, this study will also help to firmly establish whether the addition of Nimotuzumab does add to the known toxicities of chemoradiotherapy in head and neck cancer patients.

Nimotuzumab and similar agents in this class deter tumour growth by binding to and disabling a protein known as Epidermal Growth Factor Receptor (EGFR) that spurs the spread of cancerous cells. It has been shown in previous studies that the use of such agents does not enhance the known significant side-effects of standard Cisplatin and concurrent radiotherapy on the lining of mouth and throat called mucositis.

Moreover, such agents have been shown in earlier experimental studies to enhance the therapeutic effects of Cisplatin and radiotherapy against the cancer cells. A large study using another similar agent has proven the enhanced efficacy in patients when added to radiotherapy thereby confirming the findings in the laboratory. Nimotuzumab with its similar anti-cancer activity and seemingly lower skin toxicities has the potential of enhancing the efficacy of Cisplatin and concurrent radiotherapy without increasing the side-effect of mucositis.

Over 700 patients with locally advanced squamous cell carcinoma of the head and neck who have had surgery and at high risk of recurrence are expected to be involved. While other institutions are awaiting approval from their respective Institutional Review Board, NCCS has started the new therapy for its first patient.

“People tend to think that patients who volunteered for clinical trials are subjecting themselves to be treated like human guinea pigs. Contrary to that, volunteers often receive the best care possible as they are closely monitored by their doctors and research nurses,” said Prof Soo Khee Chee, Director of NCCS, who is also a specialist for head and neck cancer.

The global phase III clinical trial, which could take three or more years to complete, is a blinded study, where patients are administered weekly for an eight-week period with either Nimotuzumab or a placebo in addition to the best available standard therapy – Cisplatin and radiotherapy. Patients will then be followed up with scans once every three months where doctors look out for overall survival and recurrence rate.

Public who are interested to find out more or keen to participate in the trial can call Mr Faisal Roohi, the Clinical Project Manager at +65 6508 8345 or email faisal.roohi@scri.edu.sg.

About (NCCS)

The National Cancer Centre Singapore (NCCS) is the premier cancer research and treatment facility in Singapore and in the region. It was established in 1997 and sees about 68 per cent of the public sector medical oncology cases and about 65 per cent of radiation oncology cases. NCCS not only houses the most number of oncologists in Singapore but is also equipped with the largest number of equipment to provide the latest radiation oncology care in Singapore.

For further information, please contact :

Ms Veronica Lee
Senior Executive, Corporate Communications
Tel: 6236 9429 / 9450 4017
Email: Veronica.Lee.H.E.@nccs.com.sg

Ms Carol Ang
Executive, Corporate Communications
Tel: 6236 9424 / 9845 5354
Email: Carol.Ang.S.Y@nccs.com.sg

Mr Sunny Wee
Community and Media Relations Advisor
Tel: 9274 6922
Email: Sunny.Wee@nccs.com.sg