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

NCT ID: NCT05674305

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2027-01-01

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy alone

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.

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: DRUG

IMRT for primary and regional field

Concurrent chemoradiotherapy

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）

Group Type: ACTIVE_COMPARATOR

Radiotherapy

Intervention Type: DRUG

IMRT for primary and regional field

Cisplatin

Intervention Type: DRUG

Cisplatin 80mg/m2, 21days/cycle, 2 cycles

Interventions

Radiotherapy

IMRT for primary and regional field

Intervention Type: DRUG

Cisplatin

Cisplatin 80mg/m2, 21days/cycle, 2 cycles

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Chaosu Hu

MD and PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan Universtiy Shanghai Cancer Centre

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chengrun Du, MD and PhD

Role: CONTACT

duchengrun@qq.com

+86-15001733593

Facility Contacts

Hongmei Ying, M.D.

Role: primary

yinghongmei2011@sina.com

+8621-64175590 ext. 81400

Other Identifiers

20122229-15

Identifier Type: -

Identifier Source: org_study_id