Nasopharyngeal Carcinoma (NPC)NCT06612697
Long-term Outcomes of Early-stage Nasopharyngeal Carcinoma Patients Treated with Radiotherapy Alone
An observational study of Nasopharyngeal Carcinoma (NPC) and Oncology, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), Oncology, Radiology
- What is being tested?
- Radiology
- How many people
- 262 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Oct 2023to 1 Sep 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Nasopharyngeal Carcinoma (NPC), Oncology, Radiology
- Being tested
- Radiology
- Keywords
- nasopharyngeal carcinoma, early-stage, Radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiologyOther
A retrospective analysis was conducted using systematic records from the Department of Radiation Oncology at our hospital. The study included patients diagnosed with nasopharyngeal carcinoma through endoscopic pathological reports 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 were followed up long-term with complete medical records.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
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.
Measured: The 5-year survival rate after surgery
Disease-Free Survival
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.
Measured: Within 5 years after surgery
Local Control Rate
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.
Measured: Within 5 years after surgery
Secondary outcomes (3)
Recurrence Rate
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.
Measured: Within 5 years after surgery
Metastasis Rate
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.
Measured: Within 5 years after surgery
Treatment-Related Adverse Events
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.
Measured: Within 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start2 Oct 2023
- Primary completion1 Jul 2024
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Taichung Veterans General 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
- Retrospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612697
- Sponsor's protocol ID
- CE23408A
- Status last verified
- Sep 2024
- First submitted
- 22 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes of Early-Stage Nasopharyngeal Carcinoma Patients Treated with Radiotherapy Alone
- ClinicalTrials.gov ID
- NCT06612697
- Acronym / sponsor ID
- CE23408A
- Conditions
- Nasopharyngeal Carcinoma (NPC), Oncology, Radiology
- Keywords
- nasopharyngeal carcinoma, early-stage, Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 25 Sep 2024 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| RadiologyA retrospective analysis was conducted using systematic records from the Department of Radiation Oncology at our hospital. The study included patients diagnosed with nasopharyngeal carcinoma through endoscopic pathological reports 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 were followed up long-term with complete medical records. | Other | – |
Primary outcome
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.
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.
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.
3 secondary outcomes
Recurrence Rate
Time frame: Within 5 years after surgery
Metastasis Rate
Time frame: Within 5 years after surgery
Treatment-Related Adverse Events
Time frame: Within 5 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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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 Nasopharyngeal Carcinoma (NPC) and Oncology, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 4 inclusion and 3 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 25 Sep 2024. 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 Taiwan. 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?
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?
Overall Survival (time frame: The 5-year survival rate after surgery). 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 25 Sep 2024.