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Trial Title:
Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy
NCT ID:
NCT05674305
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cisplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Radiotherapy
Description:
IMRT for primary and regional field
Arm group label:
Concurrent chemoradiotherapy
Arm group label:
Radiotherapy alone
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin 80mg/m2, 21days/cycle, 2 cycles
Arm group label:
Concurrent chemoradiotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan Universtiy Shanghai Cancer Centre
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Ying, M.D.
Phone:
+8621-64175590
Phone ext:
81400
Email:
yinghongmei2011@sina.com
Start date:
January 1, 2022
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05674305
