Comparing radiotherapy alone to concurrent chemoradiotherapy for nasopharyngeal carcinoma patients with undetectable EBV DNA after chemotherapy

A Multicenter, Randomized, Non-inferior Phase III Study of Radiotherapy Alone Versus Concurrent Chemo-radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Complete Remission of EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

This study is testing if patients with nasopharyngeal cancer and undetectable EBV DNA after chemotherapy can safely receive just radiotherapy instead of the usual combination of chemotherapy and radiotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05674305 on ClinicalTrials.gov

What this trial studies

This multicenter randomized non-inferior study aims to evaluate the safety of omitting concurrent chemotherapy in patients with locally advanced nasopharyngeal carcinoma who have achieved undetectable levels of EBV DNA after one cycle of neoadjuvant chemotherapy. Participants will be randomly assigned to receive either radiotherapy alone or the standard concurrent chemoradiotherapy. The study focuses on patients whose EBV DNA levels do not rebound during subsequent cycles of chemotherapy, thereby identifying a potentially lower-risk group. The goal is to determine if radiotherapy alone is a safe and effective treatment option for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly confirmed non-keratinizing nasopharyngeal carcinoma who have undetectable EBV DNA after one cycle of neoadjuvant chemotherapy.

Not a fit: Patients with other types of nasopharyngeal carcinoma or those who do not meet the EBV DNA criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less intensive treatment option for patients with nasopharyngeal carcinoma, potentially reducing side effects and improving quality of life.

How similar studies have performed: Other studies have explored the role of EBV DNA levels in treatment decisions for nasopharyngeal carcinoma, suggesting that this approach may have merit, though this specific comparison is novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
2. Age 18-70 years.
3. Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer\[AJCC\] edition).
4. Patients with detectable pre-treatment plasma EBV DNA but undetectable EBV DNA after one cycle neoadjuvant and no EBV DNA rebound during the second and third cycle.
5. ECOG (Eastern Cooperative Oncology Group) score: 0-1
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 \<1.0×ULN.
8. Renal function: serum creatinine \<1×ULN.
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. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
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. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
6. Severe, uncontrolled medical conditions and infections.
7. At the same time using other test drugs or in other clinical trials.
8. Refusal or inability to sign informed consent to participate in the trial.
9. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan Universtiy Shanghai Cancer Centre — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Chengrun Du, MD and PhD

Conditions Nasopharyngeal Carcinoma