NCT06912698 Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma
| NCT ID | NCT06912698 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hai-Qiang Mai,MD,PhD |
| Condition | Nasopharyngeal Cancinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 342 participants |
| Start Date | 2025-05-22 |
| Primary Completion | 2031-04-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 342 participants in total. It began in 2025-05-22 with a primary completion date of 2031-04-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 carcinoma patients who are sensitive to radiotherapy.
Eligibility Criteria
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.
Contact & Investigator
Hai-Qiang MD, Dr.
STUDY CHAIR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT06912698 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Nasopharyngeal Cancinoma (NPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06912698 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 342 participants.
Is NCT06912698 currently recruiting?
Yes, NCT06912698 is actively recruiting participants. Contact the research team at maihq@sysucc.org.cn for enrollment information.
Where is the NCT06912698 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06912698 clinical trial?
NCT06912698 is sponsored by Hai-Qiang Mai,MD,PhD. The principal investigator is Hai-Qiang MD, Dr. at Sun Yat-Sen University Cancer Center. The trial plans to enroll 342 participants.