Status:
ACTIVE_NOT_RECRUITING
Radiotherapy Plus Nimotuzumab or Cisplatin in Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This is a phase III randomized clinical trial of definitive radiotherapy plus EGFR blocker nimotuzumab versus radiotherapy plus cisplatin(CCRT) for nasopharyngeal carcinoma (NPC) patients with favorab...
Detailed Description
Currently, NCCN (National Comprehensive Cancer Network) guidelines recommend induction chemotherapy combined with concurrent chemoradiotherapy as IIA level-evidenced treatment for locally advanced nas...
Eligibility Criteria
Inclusion
- Age 18-70, regardless of sex.
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage II-IVa (except N3)(according to the 8th American Joint Committee on Cancer\[AJCC\] edition)
- Patients with pre-treatment plasma EBV DNA\<1500 copies/mL
- Patients with plasma EBV DNA= 0 copy/mL and CR/PR according to RECIST after two cycle induction chemotherapy
- ECOG (Eastern Cooperative Oncology Group) score: 0-1
- Women in their reproductive years should ensure that they use contraception during the study period.
- Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
- Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 2.5 times the upper limit of normal value (ULN), total bilirubin \<2.0×ULN.
- Renal function: serum creatinine \<1.5×ULN
- 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
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
- Receiving radiotherapy or chemotherapy or targeted therapy previously
- 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.
- Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
- Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- Severe, uncontrolled medical conditions and infections.
- At the same time using other test drugs or in other clinical trials.
- Refusal or inability to sign informed consent to participate in the trial.
- Other treatment contraindications.
- Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
Key Trial Info
Start Date :
August 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2027
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT04456322
Start Date
August 17 2020
End Date
May 11 2027
Last Update
May 14 2025
Active Locations (1)
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1
Sun Yat-sen Universitty Cancer Center
Guangzhou, Guangdong, China, 510060