IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features

January 26, 2026 updated by: Qiaojuan Guo

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Qiaojuan Guo, Professor
  • Phone Number: +8615080013157
  • Email: fjzlec@163.com

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stage IB NPC

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age > 70 years or < 18 years
  2. Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
  3. Largest metastatic lymph-node ≥ 3 cm in the longest dimension
  4. Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
  5. Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
  6. Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)
  7. Previous radiotherapy to the head-and-neck region
  8. Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)
  9. 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
  10. History of severe hypersensitivity reactions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
IMRT along
IMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features
Radiation: IMRT along
All patients administered with definitive radiotherapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3-year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Locoregional Relapse-Free Survival
Time Frame: 3-year
Time from diagnosis to first documented locoregional recurrence before the last follow-up visit.
3-year
Distant Metastasis-Free Survival
Time Frame: 3-year
Time from diagnosis to first documented distant metastasis before the last follow-up visit
3-year
Overall Survival
Time Frame: 3-year
Time from diagnosis to death from any cause or to the last follow-up visit for patients still alive.
3-year
Safety of Radiation
Time Frame: at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months
Acute and late radiation toxicities were graded with the CTCAE criteria
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 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.
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.
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.
at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qiaojuan Guo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NPC0013.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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