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

Phase 3

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Radiotherapy; Drug: Cisplatin

• Registration Number: NCT05674305
• Lead Sponsor: Fudan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-12-30
• Study First Submitted QC: 2022-12-30
• Status Verified: 2023-01
• Study First Posted: 2023-01-06
• Last Update Submitted: 2023-01-07
• Last Update Posted: 2023-01-10
• Primary Completion: 2025-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiotherapy alone	Radiotherapy	Patients with undectable plazma EBV DNA after first cycle neoadjuvant chemotherapy using GP regimen (gemcitabine 1000mg/m2 d1,8+ cisplatin 25mg/m2 d1-3) and without rebound during the course of second and third cycle received definitive radiotherapy to head and neck region.
Concurrent chemoradiotherapy	Radiotherapy	Patients with undectable plazma EBV DNA after first cycle neoadjuvant chemotherapy using GP regimen (gemcitabine 1000mg/m2 d1,8+ cisplatin 25mg/m2 d1-3) and without rebound during the course of second and third cycle received definitive radiotherapy to head and neck region plus two cycles of concurent chemotherapy （cisplatin 80mg/m2）
Concurrent chemoradiotherapy	Cisplatin	Patients with undectable plazma EBV DNA after first cycle neoadjuvant chemotherapy using GP regimen (gemcitabine 1000mg/m2 d1,8+ cisplatin 25mg/m2 d1-3) and without rebound during the course of second and third cycle received definitive radiotherapy to head and neck region plus two cycles of concurent chemotherapy （cisplatin 80mg/m2）

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 years	Defined from date of randomization to date of first documentation of progression or death due to any cause

Secondary Outcome Measures

Name	Time	Method
change of quality of life	1 year	QoL scores were assessed for each scale by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) before induction chemotherapy, before radiotherapy, at the end of radiotherapy, at 3 months after radiotherapy, at 6 months after radiotherapy and 12 months after radiotherapy
Overall survival	2 years	Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Toxicities	2 years	Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

Trial Locations

Locations (1)

Fudan Universtiy Shanghai Cancer Centre; 🇨🇳 Shanghai, Shanghai, China