Status:
RECRUITING
Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma
Lead Sponsor:
Hai-Qiang Mai,MD,PhD
Conditions:
Nasopharyngeal Cancinoma (NPC)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 c...
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, ...
Eligibility Criteria
Inclusion
- Age 18-70, regardless of sex.
- 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).
- Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation.
- ECOG (Eastern Cooperative Oncology Group) score: 0-1.
- Women in their reproductive years should ensure that they use contraception during the study period.
- Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
- Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.5×ULN.
- Renal function: serum creatinine \<1.5×ULN or creatinine clearance rate≥60mL/min.
- 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
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
- Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation.
- Receiving radiotherapy or chemotherapy or targeted therapy previously.
- 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.
- Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
- Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- Severe, uncontrolled medical conditions and infections.
- At the same time using other test drugs or in other clinical trials.
- Refusal or inability to sign informed consent to participate in the trial.
- Other treatment contraindications.
- Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
Key Trial Info
Start Date :
May 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 19 2033
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT06912698
Start Date
May 22 2025
End Date
March 19 2033
Last Update
April 22 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Centre
Guangzhou, Guangdong, China, 510060