RGD-K5 in Head and Neck Cancer Patients
- Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.
- 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.
Head and Neck Neoplasms
|Study Design:||Time Perspective: Prospective|
|Official Title:||Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients|
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Group (a) [Those to undergo surgical excision or biopsy] patients will receive RGD-K5 scan within two weeks of conventional image evaluations. The image result will be confirmed with histopathological results.
Chemotherapy concurrent Radiation
Group (b) patients [Those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy] will receive RGD-K5 scan prior to beginning of the therapy, after induction chemotherapy, within two weeks after concurrent chemoradiotherapy and two months after completion of concurrent chemoradiotherpy; all within two weeks of conventional image evaluations.
Group (c) patients [Those with M1 disease to receive biotherapy or chemotherapy] will receive RGD-K5 scan prior to the beginning of the first line systemic therapy, two weeks after beginning of the first line systemic therapy, within two weeks of first response evaluation for the first line systemic therapy, and within two weeks after end of the first line systemic therapy; each RGD-K5 scan would be performed within two weeks of conventional image studies. The systemic therapy might be biotherapy or chemotherapy.
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.