Long-term Outcomes of Early-stage Nasopharyngeal Carcinoma Patients Treated with Radiotherapy Alone

September 22, 2024 updated by: Taichung Veterans General Hospital

Long-Term Outcomes of Early-Stage Nasopharyngeal Carcinoma Patients Treated with Radiotherapy Alone

Nasopharyngeal carcinoma (NPC) is a malignant tumor primarily originating in the nasopharynx, commonly found in populations in southern China, certain regions of Asia, and North Africa. The main treatment for NPC is primarily radiotherapy, with some patients receiving combined chemotherapy. Early-stage NPC patients can achieve adequate tumor control with radiation therapy alone. Various studies report that the 5-year survival rate for very early-stage NPC exceeds 90%. However, some stage I patients experience local recurrence or distant metastasis after treatment, indicating treatment failure. This study aims to retrospectively analyze the factors contributing to treatment failure and prognostic factors in this group of early-stage NPC patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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 (Actual)

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.
262

Contacts and Locations

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

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Taichung Veterans General Hospital

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

A retrospective analysis was conducted on patients diagnosed with nasopharyngeal carcinoma based on endoscopic pathological reports at our institution from January 1, 1984, to December 31, 2022. Eligible patients had baseline imaging (CT or MRI) prior to treatment, received definitive radiotherapy at our institution, and had long-term follow-up with complete medical records.

Description

Inclusion Criteria:

  • Diagnosed with nasopharyngeal carcinoma based on endoscopic pathological reports.
  • Included early-stage patients classified as cT1-2, cN0-1, M0.
  • Had baseline imaging (CT or MRI) prior to treatment.
  • Received definitive radiotherapy at our institution and had long-term follow-up with complete medical records.

Exclusion Criteria:

  • Excluded from the study are patients with local lymph node metastasis or distant metastasis (cN ≥ 2, M = 1) as determined by imaging studies.
  • Patients who did not receive definitive radiotherapy at our institution or had incomplete medical records during long-term follow-up are also excluded.
  • Patients diagnosed with any other primary cancer within five years prior to the diagnosis of nasopharyngeal carcinoma (excluding DCIS and skin cancer) are excluded from the study.

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

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
Overall Survival
Time Frame: The 5-year survival rate after surgery
Overall survival is an important indicator for assessing treatment efficacy, reflecting the impact of treatment on extending patient life. It is typically calculated by measuring the time from the start of treatment until the patient's death or loss to follow-up.
The 5-year survival rate after surgery
Disease-Free Survival
Time Frame: Within 5 years after surgery
Disease-free survival (DFS) refers to the period during which a patient remains free of disease recurrence following treatment. This indicator helps evaluate the effectiveness of the treatment, particularly in early-stage cancer patients, as it reflects the durability of tumor control. DFS is typically calculated by measuring the time from the end of treatment to the first occurrence of disease recurrence.
Within 5 years after surgery
Local Control Rate
Time Frame: Within 5 years after surgery
Local control rate refers to the effectiveness of treatment in managing the tumor at its primary site, reflecting the ability to prevent local recurrence. A high local control rate indicates that the treatment has successfully eradicated the tumor or effectively suppressed its growth, which is crucial for the prognosis of tumors such as nasopharyngeal carcinoma.
Within 5 years after surgery

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
Recurrence Rate
Time Frame: Within 5 years after surgery
Recurrence rate refers to the proportion of patients who experience tumor recurrence after treatment, encompassing both local recurrence and distant metastasis. This indicator aids in evaluating the overall effectiveness of the treatment and identifying potential prognostic factors, while also revealing differences between various treatment methods.
Within 5 years after surgery
Metastasis Rate
Time Frame: Within 5 years after surgery
Metastasis rate refers to the proportion of tumors that spread to other sites in the body. This indicator provides information about disease progression. A high metastasis rate may suggest more aggressive biological characteristics of the tumor and can influence the choice of treatment strategies.
Within 5 years after surgery
Treatment-Related Adverse Events
Time Frame: Within 5 years after surgery
Treatment-related adverse events refer to the side effects or complications that patients experience during the course of treatment. These events can affect the patient's quality of life and the continuity of treatment, making it crucial to understand their incidence and nature in order to assess the overall safety of the treatment.
Within 5 years after surgery

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.
Taichung Veterans General Hospital

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.
October 2, 2023

Primary Completion (Actual)

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.
July 1, 2024

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.
September 1, 2025

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).
September 22, 2024

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.
September 22, 2024

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.
September 25, 2024

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.
September 25, 2024

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.
September 22, 2024

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.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • CE23408A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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