Clinical trial · Interventional
A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma
A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
NCT00201396CI-TRIAL-00016925completedPhase 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)
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCRT | Radiation | — | UNRESOLVED |
| Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A arm
- description
- CCRT
- interventionNames
- Radiation: CCRT
- type
- EXPERIMENTAL
- label
- B arm
- description
- Induction/CCRT
- interventionNames
- Radiation: CCRT
- Drug: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin
Primary outcomes (1)
- measure
- The primary endpoint is the disease-free survival.
- timeFrame
- 10 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proved nasopharyngeal carcinoma. * T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30) * Eastern Cooperative Oncology Group performance status \< 2. * A leukocyte count ≥3750/mL, Hb ≥ 10 g/dL, and a platelet count ≥100,000/mL. * A serum bilirubin level \< 1.5 mg/dL, serum creatinine level \< 1.6 mg/dL or creatinine clearance \> 60 mL/min. * Age less than 70 years old * An informed consent signed. Exclusion Criteria: * Evidence of metastatic disease. * Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin. * Presence of uncontrolled hypertension, poorly controlled heart failure. * Presence of active infection. * Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies. * Women who test positive for pregnancy.
References
Publications (1)
- DERIVEDHong RL, Hsiao CF, Ting LL, Ko JY, Wang CW, Chang JTC, Lou PJ, Wang HM, Tsai MH, Lai SC, Liu TW. Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. Ann Oncol. 2018 Sep 1;29(9):1972-1979. doi: 10.1093/annonc/mdy249. PMID 30016391