Nasopharyngeal CarcinomaNCT03588403
TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients
An observational study of Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- TOMO and IMRT
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Jul 2022
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: nasopharyngeal carcinoma patients staged T1-4N0-3M0
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing carcinoma.
- Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
- Performance status: KPS>70
- With normal liver function test (ALT, AST <1.5ULN)
- Renal: creatinine clearance >60ml/min
- Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.
- Written informed consent
Who cannot join
- WHO type I squamous cell carcinoma or adenocarcinoma
- Age >65 or <18
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- Patient is pregnant or lactating
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaozhong Chen
Hangzhou, Zhejiang, 310022
Xiaozhong Chen, MD, +86-571-88128202, cxzfyun@sina.com
About this study
Official title: Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study
Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- TOMO, IMRT
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOMORadiation
Tomotherapy
IMRTRadiation
Intensity modulated radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A:Tomotherapy | Patients with non-disseminated nasopharyngeal carcinoma receiving Tomotherapy.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F. Receives: Radiation: TOMO | |
| Arm B: IMRT | Patients with non-disseminated nasopharyngeal carcinoma receiving IMRT.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F. Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoL(quality of life)
Changes in quality of life were assessed by EORTC QLQ-C30
Measured: 2 years
Secondary outcomes (4)
PFS (progression free survival)
from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ).
Measured: 2 years
OS (overall survival)
from the first day of therapy to death or last follow-up
Measured: 2 years
LRRFS(Locoregional failure-free survival)
from the first day of therapy to the date of first locoregional relapse or until the date of the last follow-up visit.
Measured: 2 years
Adverse Events
Participants will be followed for the duration of hospital stay, an expected average of 50 days and every 3 months thereafter for 5 years. Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE 4.03 during the chemoradiation and follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Jul 2018
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaozhong, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588403
- Sponsor's protocol ID
- IRB-2018-133
- Status last verified
- Jul 2018
- First submitted
- 4 Jul 2018
- Last updated
- 20 Jul 2018
- Results posted
- 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 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study
- ClinicalTrials.gov ID
- NCT03588403
- Acronym / sponsor ID
- IRB-2018-133
- Conditions
- Nasopharyngeal Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 17 Jul 2018 (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.
Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A:Tomotherapy | – | Radiation: TOMOPatients with non-disseminated nasopharyngeal carcinoma receiving Tomotherapy.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F. |
| Arm B: IMRT | – | Radiation: IMRTPatients with non-disseminated nasopharyngeal carcinoma receiving IMRT.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- nasopharyngeal carcinoma patients staged T1-4N0-3M0
Key inclusion criteria (7 listed)
- Patients with newly histologically confirmed non-keratinizing carcinoma.
- Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
- Performance status: KPS>70
- With normal liver function test (ALT, AST <1.5ULN)
- Renal: creatinine clearance >60ml/min
Key exclusion criteria (7 listed)
- WHO type I squamous cell carcinoma or adenocarcinoma
- Age >65 or <18
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- Patient is pregnant or lactating
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 |
|---|---|---|
| TOMOTomotherapy | Radiation | Arm A:Tomotherapy |
| IMRTIntensity modulated radiotherapy | Radiation | Arm B: IMRT |
Primary outcome
QoL(quality of life)
Time frame: 2 years
Changes in quality of life were assessed by EORTC QLQ-C30
4 secondary outcomes
PFS (progression free survival)
Time frame: 2 years
OS (overall survival)
Time frame: 2 years
LRRFS(Locoregional failure-free survival)
Time frame: 2 years
Adverse Events
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- 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.
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 Nasopharyngeal Carcinoma, run by Zhejiang Cancer Hospital at 1 site in China.
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 7 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: status not confirmed, as of the sponsor's last update on 20 Jul 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoL(quality of life) (time frame: 2 years). 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 20 Jul 2018.