Overview

Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy

Status:
Recruiting

Trial end date:
2027-01-01

Target enrollment:
0

Participant gender:
All

Summary

The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fudan University

Treatments:

Cisplatin

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