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

NCT06612697 | Active Not Recruiting DMC

• 1 other identifier: CE23408A
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma (NPC); Oncology; Radiology

Keywords

nasopharyngeal carcinoma; early-stage; Radiotherapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Recurrence Rate

  Within 5 years after surgery

• Metastasis Rate

  Within 5 years after surgery

• Treatment-Related Adverse Events

  Within 5 years after surgery

Interventions

Radiology OTHER

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: October 2, 2023
• Primary Completion: July 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

TW (1)