NCT03352778

IMRT vs 2DRT for NPC Patients

Completed Last updated 22 October 2021

What this trial tests

trial testing IMRT in NPC in 60 participants. Completed in 30 June 2021.

Timeline

29 November 2017

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Chinese University of Hong Kong
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	29 November 2017
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Hong Kong

Drugs / interventions tested

• IMRT
• 2DRT

Conditions studied

• NPC — all drugs for NPC →

Sponsor

Chinese University of Hong Kong

Who can join

Eligibility, any sex, with NPC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Irradiation of the parotid gland with subsequent long-term xerostomia is a well-recognized complication after radiotherapy for head and neck (HAN) cancers. A number of studies have shown that IMRT could minimize the radiation dose to the parotid glands and hence the risk of developing xerostomia. The benefit of IMRT has also been demonstrated in prior dosimetric and non-randomized studies in NPC patients. In 2007, the investigators have published the prospective randomized study of IMRT versus 2DRT in early stage NPC patients. In the study, IMRT had lower incidence of observer-rated severe xerostomia, higher parotid and whole saliva flow rate, than patients in 2DRT arm at 1 year after treatment. However, there was no significant difference in patient-reported outcome, i.e. subjective xerostomia scoring, between the 2 arms. The underlying reason for the incoherent findings in terms of objective and subjective xerostomia outcome remains uncertain. One of the possible explanations for this observation could be the better parotidsparing with IMRT alone may not entirely sufficient to maintain oral cavity lubrication while the other mucin-secretory salivary gland protection is also essential. Another possible explanation for the insignificant improvement in patient-reported outcome with IMRT is the short follow-up time. Gradual recovery or improvement in various quality of life parameters was not uncommonly seen several years after definitive radiotherapy for HAN cancer patients. There is much interest in studying the long term clinical outcome, especially the treatment-related complications, for the patients who had randomized and treated in the prior presented prospective study.

In this study, the long term results, in particular the xerostomia rating will be assessed and compared in NPC patients who had participated in the prior reported prospective randomized study of IMRT vs 2DRT.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.