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RECRUITING

NCT06912698

PHASE3

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

Sponsor: Hai-Qiang Mai,MD,PhD

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

342

Start Date

2025-05-22

Completion Date

2033-03-19

Last Updated

2025-04-22

Healthy Volunteers

Conditions

Nasopharyngeal Cancinoma (NPC)

Interventions

RADIATION

Reduced dose radiation

Reduced dose group would receive 61.48Gy radiation.

RADIATION

Standard dose radiation

Standard dose group would receive 69.96Gy radiation.

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.

Locations (1)

Sun Yat-sen University Cancer Centre

Guangzhou, Guangdong, China