drugset / Trial / NCT01086488

Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma

NCT01086488 ↗

Phase 2 Unknown 66 enrolled Ministry of Health, Malaysia
RandomizedParallel-groupOpen-labelTreatment

Summary

Objectives: Primary objective \- To determine the efficacy of Foscan-PDT compared with Brachytherapy for recurrent or persistent NPC, as determined by macroscopic clinical examination, CT scan and biopsy. The primary endpoint is complete tumour response at 6 months. Secondary objective: * To determine the response rates, e.g. presence of tumour on endoscopy, time to progression and overall survival in patients treated with Foscan-PDT compared with brachytherapy * To determine the quality of life, as derived from the University of Washington Quality of Life questionnaire in patients treated with Foscan-PDT compared with brachytherapy * To evaluate the safety of Foscan-PDT compared with brachytherapy in terms of adverse events and serious adverse events.

Timeline

Start
2009-01
Primary completion
2011-09
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject FOSCAN Unknown 0.1 mg/kg —