IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features

Intensity-Modulated Radiotherapy Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features

This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Cancinoma (NPC); Intensity-modulated Radiotherapy; Stage IB
• Intervention / Treatment: Radiation: IMRT along

• Study Type: Observational
• Enrollment (Estimated): 169

Contacts and Locations

• Study Contact: Name: Qiaojuan Guo, Professor; Phone Number: +8615080013157; Email: fjzlec@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Qiaojuan Guo, Professor; Phone Number: +8615080013157; Email: guoqiaojuan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Stage IB NPC

Description

Inclusion Criteria:

1. Histopathologically confirmed, newly diagnosed nasopharyngeal carcinoma 3. Age 18-70 years 4. Stage IB disease (T1-2N1M0) per the 9th edition AJCC/UICC staging system 5. Upper-neck nodal metastasis only: inferior border of every positive node at or above the inferior border of the hyoid bone 6. ECOG performance status 0-2 7. Adequate bone-marrow function

Exclusion Criteria:

1. Age > 70 years or < 18 years
2. Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
3. Largest metastatic lymph-node ≥ 3 cm in the longest dimension
4. Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
5. Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
6. Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)
7. Previous radiotherapy to the head-and-neck region
8. Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)
9. Any severe comorbidity that would confer unacceptable risk or compromise protocol adherence, including but not limited to unstable cardiac disease, renal failure, chronic hepatitis, or uncontrolled psychiatric disorder
10. History of severe hypersensitivity reactions

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IMRT along; IMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features	Radiation: IMRT along; All patients administered with definitive radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-Free Survival	Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.	3-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional Relapse-Free Survival	Time from diagnosis to first documented locoregional recurrence before the last follow-up visit.	3-year
Distant Metastasis-Free Survival	Time from diagnosis to first documented distant metastasis before the last follow-up visit	3-year
Overall Survival	Time from diagnosis to death from any cause or to the last follow-up visit for patients still alive.	3-year
Safety of Radiation	Acute and late radiation toxicities were graded with the CTCAE criteria	at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months
Quality of life (EORTC QLQ C30)	Quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ C30), the range is 0-100, higher scores mean a worse outcome.	at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.
Quality of life score QLQ-HN35	The quality of life score was calculated according to the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire QLQ-HN35; the range is 0-100, with higher scores indicating a worse outcome.	at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.

Collaborators and Investigators

• Sponsor: Qiaojuan Guo

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Stage IB; Nasopharyngeal Cancinomar; RT along
• Other Study ID Numbers: NPC0013.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No