Comparing reduced dose and standard dose radiotherapy for early stage nasopharyngeal carcinoma

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 is testing if a lower dose of radiotherapy is just as effective as the standard dose for patients with early stage nasopharyngeal carcinoma who have responded well to initial treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 342 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06912698 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of reduced dose radiotherapy compared to standard dose radiotherapy in patients with early stage nasopharyngeal carcinoma. Patients will receive intensity-modulated radiotherapy and will be randomized into two groups: one receiving reduced dose treatment and the other receiving standard dose treatment. The primary goal is to determine if the reduced dose is non-inferior in terms of 3-year locoregional relapse-free survival rates. The study includes patients with stage I nasopharyngeal carcinoma who are sensitive to radiotherapy and have achieved complete response after initial treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed, histologically confirmed non-keratinizing nasopharyngeal carcinoma at clinical stage I.

Not a fit: Patients with advanced stages of nasopharyngeal carcinoma or those who do not respond to initial radiotherapy will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to less intensive treatment options for patients, potentially reducing side effects while maintaining effective cancer control.

How similar studies have performed: Other studies have explored reduced dose radiotherapy approaches, showing promising results, but this specific comparison is novel.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Centre — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Hai-Qiang Mai, Dr.

Conditions: Nasopharyngeal Cancinoma, radiotherapy, dose