Nasopharyngeal Cancinoma (NPC)NCT07376603
IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
An observational study of Nasopharyngeal Cancinoma (NPC) and Intensity-modulated Radiotherapy, run by Qiaojuan Guo at 1 site in China.
Trial summary
This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC), Intensity-modulated Radiotherapy, Stage IB
- What is being tested?
- IMRT along
- Type of treatment
- Surgery or procedure
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2026to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage IB NPC
Who may be able to join
- 1. Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma 3. Age 18-70 years 4. Stage IB disease (T1-2N1M0) per the 9th edition AJCC/UICC staging system 5. Upper-neck nodal metastasis only: inferior border of every positive node at or above the inferior border of the hyoid bone 6. ECOG performance status 0-2 7. Adequate bone-marrow function
Who cannot join
- Age > 70 years or < 18 years
- Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
- Largest metastatic lymph-node ≥ 3 cm in the longest dimension
- Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
- Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
- Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)
Show all 10Show fewer
- Previous radiotherapy to the head-and-neck region
- Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)
- Any severe comorbidity that would confer unacceptable risk or compromise protocol adherence, including but not limited to unstable cardiac disease, renal failure, chronic hepatitis, or uncontrolled psychiatric disorder
- History of severe hypersensitivity reactions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Qiaojuan Guo, Professor, +8615080013157, guoqiaojuan@163.com
About this study
Official title: Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach
- Being tested
- IMRT along
- Keywords
- Nasopharyngeal Cancinomar, Stage IB, RT along
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT alongRadiation
All patients administered with definitive radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| IMRT along | IMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features Receives: Radiation: IMRT along |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-Free Survival
Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.
Measured: 3-year
Secondary outcomes (6)
Locoregional Relapse-Free Survival
Time from diagnosis to first documented locoregional recurrence before the last follow-up visit.
Measured: 3-year
Distant Metastasis-Free Survival
Time from diagnosis to first documented distant metastasis before the last follow-up visit
Measured: 3-year
Overall Survival
Time from diagnosis to death from any cause or to the last follow-up visit for patients still alive.
Measured: 3-year
Safety of Radiation
Acute and late radiation toxicities were graded with the CTCAE criteria
Measured: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months
Quality of life (EORTC QLQ C30)
Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30), the range is 0-100, higher scores mean a worse outcome.
Measured: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.
Quality of life score QLQ-HN35
The quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35; the range is 0-100, with higher scores indicating a worse outcome.
Measured: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start12 Jan 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Qiaojuan Guo
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Qiaojuan Guo, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376603
- Sponsor's protocol ID
- NPC0013.1
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
- ClinicalTrials.gov ID
- NCT07376603
- Acronym / sponsor ID
- NPC0013.1
- Keywords
- Nasopharyngeal Cancinomar, Stage IB, RT along
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- Qiaojuan GuoOther government
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 29 Jan 2026 (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.
This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT along | – | Radiation: IMRT alongIMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage IB NPC
Key inclusion criteria (1 listed)
- 1. Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma 3. Age 18-70 years 4. Stage IB disease (T1-2N1M0) per the 9th edition AJCC/UICC staging system 5. Upper-neck nodal metastasis only: inferior border of every positive node at or above the inferior border of the hyoid bone 6. ECOG performance status 0-2 7. Adequate bone-marrow function
Key exclusion criteria (10 listed)
- Age > 70 years or < 18 years
- Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
- Largest metastatic lymph-node ≥ 3 cm in the longest dimension
- Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
- Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
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 |
|---|---|---|
| IMRT alongAll patients administered with definitive radiotherapy | Radiation | IMRT along |
Primary outcome
Relapse-Free Survival
Time frame: 3-year
Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.
6 secondary outcomes
Locoregional Relapse-Free Survival
Time frame: 3-year
Distant Metastasis-Free Survival
Time frame: 3-year
Overall Survival
Time frame: 3-year
Safety of Radiation
Time frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months
Quality of life (EORTC QLQ C30)
Time frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.
Quality of life score QLQ-HN35
Time frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Cancinoma (NPC) and Intensity-modulated Radiotherapy, run by Qiaojuan Guo 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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiaojuan Guo, Professor (+8615080013157, fjzlec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-Free Survival (time frame: 3-year). 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 29 Jan 2026.