Clinical trial NCT06612697: Long-term Outcomes of Early-stage Nasopharyngeal Carcinoma Patients Treated with Radiotherapy Alone
Official title: Long-Term Outcomes of Early-Stage Nasopharyngeal Carcinoma Patients Treated with Radiotherapy Alone
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Nasopharyngeal Carcinoma (NPC)
Oncology
Radiology
Keywords: nasopharyngeal carcinoma
early-stage
Radiotherapy
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 262
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: The 5-year survival rate after surgery
measure: Disease-Free Survival
timeFrame: Within 5 years after surgery
measure: Local Control Rate
timeFrame: Within 5 years after surgery
Secondary outcomes:
measure: Recurrence Rate
timeFrame: Within 5 years after surgery
measure: Metastasis Rate
timeFrame: Within 5 years after surgery
measure: Treatment-Related Adverse Events
timeFrame: Within 5 years after surgery
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: