NPCNCT03352778
IMRT vs 2DRT for NPC Patients
An observational study of NPC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NPC
- What is being tested?
- IMRT and 2DRT
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Nov 2017to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The NPC patient, who had been enrolled, randomized and treated in the prior prospective randomized study of IMRT vs 2DRT.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- NPC
- Being tested
- IMRT, 2DRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
66Gy by intensity-modulated radiotherapy
2DRTRadiation
66Gy by 2-dimensional radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| IMRT | Not described Receives: Radiation: IMRT | |
| 2DRT | Not described Receives: Radiation: 2DRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (3)
To measure the difference of the incidence of loco-regional recurrence between 2DRT vs IMRT.
Measured: 2 years
To measure the difference of the overall survival and progression-free survival between 2DRT vs IMRT.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start29 Nov 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NPCStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352778
- Sponsor's protocol ID
- NPC031
- Status last verified
- Oct 2021
- First submitted
- 15 Nov 2017
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03352778
- Acronym / sponsor ID
- NPC031
- Conditions
- NPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMRT | – | Radiation: IMRT |
| 2DRT | – | Radiation: 2DRT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The NPC patient, who had been enrolled, randomized and treated in the prior prospective randomized study of IMRT vs 2DRT.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMRT66Gy by intensity-modulated radiotherapy | Radiation | IMRT |
| 2DRT66Gy by 2-dimensional radiotherapy | Radiation | 2DRT |
Primary outcome
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
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
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
3 secondary outcomes
To measure the difference of the incidence of loco-regional recurrence between 2DRT vs IMRT.
Time frame: 2 years
To measure the difference of the overall survival and progression-free survival between 2DRT vs IMRT.
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NPC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.