IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without... | NCT07376603

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

NCT07376603

Sponsor

Qiaojuan Guo

Status

Recruiting

Last Update Posted

Jan 29, 2026Actual

Enrollment

169Estimated

Phase

Not provided

Conditions

Nasopharyngeal Cancinoma (NPC)
Intensity-modulated Radiotherapy
Stage IB

Interventions

IMRT along

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2026Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Jan 17, 2026

First Submission Date that Met QC Criteria

Jan 26, 2026

First Posted Date

Jan 29, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2026

Last Update Posted Date

Jan 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

169Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMRT along		IMRT Alone for 169 Patients with Stage IB Nasopharyngeal Carcinoma Without High-Risk Features	Radiation: IMRT along

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMRT along	Radiation	All patients administered with definitive radiotherapy	IMRT along

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Stage IB NPC

Sampling Method

Non-Probability Sample