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

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: Active, not recruiting
• Conditions: Oncology; Radiology; Nasopharyngeal Carcinoma (NPC)
• Intervention / Treatment: Other: Radiology

• Study Type: Observational
• Enrollment (Actual): 262

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Within 5 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Within 5 years after surgery

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 22, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 22, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Radiotherapy; nasopharyngeal carcinoma; early-stage
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID 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