Clinical trial · Interventional
Sequential or Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced NPC
Non-inferiority Prospective Randomized Trial Comparing Sequential Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
NCT03366415CI-TRIAL-00056880unknownPhase 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 purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.
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 Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine and cisplatin (Induction and adjuvant chemotherapy) | Drug | — | UNRESOLVED |
| gemcitabine and cisplatin (Induction chemotherapy) | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
| IMRT and concurrent cisplatin | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy+IMRT+adjuvant chemotherapy
- description
- Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), followed by gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles.
- interventionNames
- Drug: gemcitabine and cisplatin (Induction and adjuvant chemotherapy)
- Radiation: IMRT
- type
- ACTIVE_COMPARATOR
- label
- Induction chemotherapy+IMRT and concurrent cisplatin
- description
- Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25 mg/m² d1-3) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 30 mg/m² every week.
- interventionNames
- Drug: gemcitabine and cisplatin (Induction chemotherapy)
- Radiation: IMRT and concurrent cisplatin
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type) * Tumor staged as III-IVA (according to the 8th AJCC edition). * Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. * Age between 18 and 65 years old. * Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL. * Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN. * Adequate renal function: creatinine clearance ≥60 ml/min. * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * Evidence of distant metastasis * Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or nodes. * Other previous or concomitant cancer. * Pregnancy or lactation. * Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, immune deficiency, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or emotional disturbance.
References
Publications (1)
- DERIVEDXue F, Ou D, Xie C, Lin S, Li J, Chen X, Zhang F, Ying H, Lu X, Shen C, Xu T, Ou X, Li W, Zhou X, Du C, Zhou C, Hu C, He X. Sequential vs Induction Plus Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2025 Jul 24;11(9):1011-20. doi: 10.1001/jamaoncol.2025.2191. Online ahead of print. PMID 40705321