Clinical trial · Interventional
Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma
A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
NCT01528618CI-TRIAL-00054245completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The present study will be a randomized, control, multicenter phase III study of recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population consists of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil and cisplatin | Drug | — | UNRESOLVED |
| gemcitabine and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gemcitabine and cisplatin
- description
- gemcitabine 1,000 mg/m2 over 30 to 60 minutes on days 1, 8, and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
- interventionNames
- Drug: gemcitabine and cisplatin
- type
- ACTIVE_COMPARATOR
- label
- 5-Fluorouracil and cisplatin
- description
- 5-Fluorouracil 4,000 mg/m2 CIV over 96 hours and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.
- interventionNames
- Drug: 5-Fluorouracil and cisplatin
Primary outcomes (1)
- measure
- Progression free survival (PFS) assessed by independent image committee and the investigators
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven NPC diagnosis * Elder than 18 years old are inclusive * Recurrence or metastatic nasopharyngeal carcinoma with evidence of unsuitable for local treatment * Amenable to regular follow-up * Subjects with at least one measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable). * Performance status: 0-1(ECOG) * WBC \> 4.0X109/L, PLT \> 100X109/L, with normal hepatic function(AST, ALT \< 2.5 x upper limit of normal , and bilirubin \< 1.5 x upper limit of normal), with normal renal function (Creatinine \< 1.5 x upper limit of normal) * No chemotherapy or radical radiotherapy received within 6 months prior to enrollment * Life expectancy over twelve weeks * Signed and dated informed consent before the start of specific protocol procedures * Ability to comply with trial requirements. Exclusion Criteria: * Patient suitable for local treatment (eg. radiotherapy) * Active clinically serious infections (\> grade 2 NCI-CTC version 3.0) * Patient with central nervous system metastasis * Patient life threatening medical condition * Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial. * Performance status ≥ 2 * With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events \[NCI CTC\] grade ≥ 2) * Serious concurrent illness * Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors\[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry. * Patient refusing participation
References
Publications (2)
- DERIVEDHong S, Zhang Y, Yu G, Peng P, Peng J, Jia J, Wu X, Huang Y, Yang Y, Lin Q, Xi X, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C, Fang W, Zhang L. Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study. J Clin Oncol. 2021 Oct 10;39(29):3273-3282. doi: 10.1200/JCO.21.00396. Epub 2021 Aug 11. PMID 34379443
- DERIVEDZhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23. PMID 27567279