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IMRT vs 2DRT for NPC Patients

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ClinicalTrials.gov Identifier: NCT03352778
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

Brief Summary:

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.


Condition or disease Intervention/treatment
NPC Radiation: IMRT Radiation: 2DRT

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Long Term Results of the Prospective Randomized Study of Intensity-modulated Radiotherapy (IMRT) Versus Two-dimensional Radiotherapy (2DRT) in Early Stage Nasopharyngeal Carcinoma (NPC) Patients
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
IMRT Radiation: IMRT
66Gy by intensity-modulated radiotherapy

2DRT Radiation: 2DRT
66Gy by 2-dimensional radiotherapy




Primary Outcome Measures :
  1. To measure QOL difference between 2DRT vs IMRT by EORTC QLQ-C30 core questionnaire. A 10-point difference of mean scores of QOL between groups were significant. [ Time Frame: 2 years ]
  2. To measure QOL difference between 2DRT vs IMRT by EORTC QLQ-H&N 35 questionnaire. A 10-point difference of mean scores of QOL between groups were significant. [ Time Frame: 2 years ]
  3. To measure difference in xerostomia score between 2DRT vs IMRT by using the xerostomia questionnaire (6-item xerostomia questionnaire. Johnson et al). A low score indicates worse xerostomia. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To measure the difference of the incidence of loco-regional recurrence between 2DRT vs IMRT. [ Time Frame: 2 years ]
  2. To measure the difference of the overall survival and progression-free survival between 2DRT vs IMRT. [ Time Frame: 2 years ]
  3. To measure the difference of numbers of 2DRT vs IMRT patients with treatment-related adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Criteria. [ Time Frame: 2 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The NPC patient, who had been enrolled, randomized and treated in the prior prospective randomized study of IMRT vs 2DRT.
Criteria

Inclusion Criteria:

  • The NPC patient, who had been enrolled, randomized and treated in the prior prospective randomized study of IMRT vs 2DRT.
  • Regular follow-up for more than five years from the end of study intervention (i.e. IMRT or 2DRT for NPC).
  • Patient is able to sign the study-specific informed consent.
  • ECOG performance status 0 or 1.
  • Patient is able to complete the study's questionnaire.

Exclusion Criteria:

  • NPC patients who had not been randomized or allocated to the study intervention, even though had been enrolled in the prior reported study.
  • Loss of regular follow-up from the end of study intervention.
  • Regular follow-up for less than five years from the end of study intervention.
  • Patients with known recurrent or metastatic disease.
  • Patients with secondary malignancy occurred after completion of the previous study's treatment (i.e. radiotherapy).
  • Active untreated infections
  • Major medical or psychiatric illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352778


Contacts
Contact: Darren POON, FHKCR 3505 2117 mc_poon@clo.cuhk.edu.hk

Locations
Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Darren POON, FRCP    3505 2117    mc_poon@clo.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong

Responsible Party: CCTU, Honorary clinical assistant professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03352778     History of Changes
Other Study ID Numbers: NPC031
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No