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

NCT07376603 | Recruiting DMC

• 1 other identifier: NPC0013.1
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Cancinoma (NPC); Intensity-modulated Radiotherapy; Stage IB

Keywords

Nasopharyngeal Cancinomar; Stage IB; RT along

Outcome Measures

Primary Outcomes (1)

• Relapse-Free Survival

  Time from diagnosis to the disease relapse (either locoregional recurrence or distant metastasis) or death from any cause.

  3-year

Secondary Outcomes (6)

• Locoregional Relapse-Free Survival

  3-year

• Distant Metastasis-Free Survival

  3-year

• Overall Survival

  3-year

• Safety of Radiation

  at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months

• Quality of life (EORTC QLQ C30)

  at inclusion, 3 months, 6 months,12 months, 24 months, 36 months, and 60 months.

Study Arms (1)

IMRT along

IMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features

Radiation: IMRT along

Interventions

IMRT along RADIATION

All patients administered with definitive radiotherapy

IMRT along

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage IB NPC

You may qualify if:

• \. 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

You may not qualify if:

• Age \> 70 years or \< 18 years
• Matted lymph nodes: two or more contiguous nodes with loss of intervening fat planes and/or extracapsular extension forming a confluent mass
• Largest metastatic lymph-node ≥ 3 cm in the longest dimension
• Lower-neck nodal metastasis: inferior border of any positive node below the inferior border of the hyoid bone
• Prior malignancy except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix
• Pregnancy or lactation (serum pregnancy test required for women of child-bearing potential; effective contraception mandatory during treatment)
• Previous radiotherapy to the head-and-neck region
• Prior chemotherapy or surgery for the primary tumour or metastatic nodes (diagnostic procedures excluded)
• 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
• History of severe hypersensitivity reactions

Sponsors & Collaborators

• Qiaojuan Guo: lead

Study Sites (1)

Fujian Cancer Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Central Study Contacts

Qiaojuan Guo, Professor

CONTACT

+8615080013157; fjzlec@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 29, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)