Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma

April 16, 2025 updated by: Hai-Qiang Mai,MD,PhD

A Phase III Randomized Controlled Non-Inferiority Clinical Trial Comparing Reduced-Dose Versus Standard-Dose Radiotherapy Based on Treatment Response in Early-Stage Nasopharyngeal Carcinoma

This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All the patients receive intensity-modulated radiotherapy. If patients receive CR and EBV DNA undetectable when completing 50.88Gy radiation, they will continue to receive radiotherapy until 61.48Gy, then the patients would be randomised assigned ( 1:1 ) to reduced dose group (observation) or standard dose group (continue to receive radiotherapy until 69.96Gy). Patients with stage IA will receive radiotherapy alone, and patients with stage IB will receive concurrent chemoradiotherapy. For patients with stage IB, those assigned to reduced dose group will receive a total of 2 cycles cisplatin concurrent chemotherapy, with 100mg/m2 per cycle; those assigned to standard dose group will receive a total of 3 cycles cisplatin concurrent chemotherapy, with 100mg/m2 per cycle. This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy. The primary endpoint is 3-year locoregional relapse-free survival.

Study Type

Interventional

Enrollment (Estimated)

342

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-70, regardless of sex.
  2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I (according to the 9th American Joint Committee on Cancer[AJCC] edition).
  3. Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation.
  4. ECOG (Eastern Cooperative Oncology Group) score: 0-1.
  5. Women in their reproductive years should ensure that they use contraception during the study period.
  6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
  7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.5×ULN.
  8. Renal function: serum creatinine <1.5×ULN or creatinine clearance rate≥60mL/min.
  9. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

Exclusion Criteria:

  1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
  2. Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation.
  3. Receiving radiotherapy or chemotherapy or targeted therapy previously.
  4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
  5. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
  6. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
  7. Severe, uncontrolled medical conditions and infections.
  8. At the same time using other test drugs or in other clinical trials.
  9. Refusal or inability to sign informed consent to participate in the trial.
  10. Other treatment contraindications.
  11. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reduced dose group
Patients receive reduced dose radiotherapy.
Radiation: Reduced dose radiation
Reduced dose group would receive 61.48Gy radiation.
Active Comparator: Standard dose group
Patients receive standard dose radiotherapy.
Radiation: Standard dose radiation
Standard dose group would receive 69.96Gy radiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Locoregional relapse-free survival
Time Frame: 3 year
The time from randomization to either documented local and/or regional relapse or death from any cause,whichever occurred first.
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 3 year
Time from randomisation to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occurr first.
3 year
Overall survival
Time Frame: 3 year
Time from randomisation to death from any cause or censored at the date of the last follow-up.
3 year
Distant metastasis-free survival
Time Frame: 3 year
Time from randomistion to distant metastasis or death from any cause.
3 year
Incidence rate of adverse events (AEs)
Time Frame: 3 year
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
3 year
Change of quality of life (QoL) score
Time Frame: 1 year
QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer (EORTC ) Quality of Life Questionnaire C30 (QLQ-C30) and EORTC QLQ-Head and Neck module (QLQ-H&N35) at 61.48Gy radiotherapy, at 1 month after radiotherapy, at 6 month after radiotherapy, and 12 month after radiotherapy.All of the scales and items ranged in score from 0 to 100. A high score for a functional or global QoL scale represents a relatively high/healthy level of functional or global QoL, whereas a high score for a symptom scale or item represents a high number of symptoms or problems.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hai-Qiang Mai,MD,PhD

Investigators

  • Study Chair: Hai-Qiang MD, Dr., Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 22, 2025

Primary Completion (Estimated)

April 19, 2031

Study Completion (Estimated)

March 19, 2033

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-FXY-129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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