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

NCT01086488 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2011-07-08

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

FOSCAN

Patients will be randomised to one of two treatment groups. The first group of 26 patients will receive 0.1 mg/kg Foscan® at a drug-light interval of 48 hours (2 days). A single surface illumination light dose of 20 J/cm2 fluence rate of 50 mW at 652 nm will be used. The second reference group of 26 patients will be treated by intracavitary brachytherapy

Sponsors & Collaborators

  • Ministry of Health, Malaysia

    lead OTHER_GOV

Principal Investigators

  • Yoke Yeow Yap, MD · University Putra Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01086488 on ClinicalTrials.gov