A Phase 3 interventional study of Adjuvant chemotherapy (gemcitabine and cisplatin) in Nasopharyngeal Cancer, sponsored by Chinese University of Hong Kong. Completed at 6 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-17.
Sponsored by Chinese University of Hong Kong · Phase 3, Interventional, and Treatment
The purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in high risk NPC patients with residual EBV DNA following primary radiotherapy with or without concurrent cisplatin.
816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.
This study's enrollment of 104 is above the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients must have adequate organ and marrow function as defined below:
leukocytes >3,000/L; absolute neutrophil count >1,500/L; platelets >100,000/L; total bilirubin \<1.5 X institutional upper limit of normal; AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal; Creatinine clearance > 50 ml/min
Exclusion Criteria:
Adjuvant chemotherapy and then clinical follow-up and surveillance
Drug: Adjuvant chemotherapy (gemcitabine and cisplatin)
Clinical follow-up and surveillance only
Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles
Relapse free survival
Time frame: 5 years
Overall survival
Overall survival is defined as the duration from the date of randomization to the date of death due to all causes or censored at the date of last follow-up
Time frame: 5 years
Loco-regional control
Time frame: 5 years
Metastasis-free survival
Time frame: 5 years
Toxicity of adjuvant chemotherapy
Time frame: 6 months
Correlation of plasma EBV DNA and PET/CT scan with clinical course and outcome
Time frame: 5 years
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong