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RGD-K5 in Head and Neck Cancer Patients

Head and Neck Neoplasms Clinical Trial

Official title:
Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients

Clinical Trial Summary

1. Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.

2. Secondary endpoint(s): To expand the safety database of [F-18]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.

Clinical Trial Description

This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 3 year. Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified. Each participant must fulfill all the inclusion and exclusion criteria. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01447134
Study type Observational
Source Chang Gung Memorial Hospital
Contact
Status Enrolling by invitation
Phase N/A
Start date June 2011
Completion date June 2014
View Details
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