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

Last updated: April 16, 2025
Sponsor: Hai-Qiang Mai,MD,PhD
Overall Status: Active - Recruiting

Phase

3

Condition

Nasopharyngeal Cancer

Treatment

Standard dose radiation

Reduced dose radiation

Clinical Study ID

NCT06912698
2024-FXY-129
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-70, regardless of sex.

  2. Patients with newly histologically confirmed non-keratinizing nasopharyngealcarcinoma, type of WHO II or III, clinical stage I (according to the 9th AmericanJoint Committee on Cancer[AJCC] edition).

  3. Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gyradiation.

  4. ECOG (Eastern Cooperative Oncology Group) score: 0-1.

  5. Women in their reproductive years should ensure that they use contraception duringthe 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)< 1.5times 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 therequirements of visits, treatment, laboratory tests and other research requirementsstipulated in the research schedule.

Exclusion

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 thepotentially dangerous effects of the preparative chemotherapy on the fetus orinfant.

  5. Suffered from other malignant tumors (except the cure of basal cell carcinoma oruterine cervical carcinoma in situ) previously.

  6. Patients with significantly lower heart, liver, lung, kidney and bone marrowfunction.

  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 forcivil conduct.

Study Design

Total Participants: 342
Treatment Group(s): 2
Primary Treatment: Standard dose radiation
Phase: 3
Study Start date:
May 22, 2025
Estimated Completion Date:
March 19, 2033

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Centre

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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