Clinical trial · Interventional
A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients
A Phase III Study of Radiotherapy With or Without Adjuvant Chemotherapy in Advanced Stage Nasopharyngeal Carcinoma Patients
NCT00201344CI-TRIAL-00003296terminatedPhase 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)
* To investigate the efficacy of adjuvant PFL chemotherapy after radiotherapy vs radiotherapy alone in AJC stage IV nasopharyngeal carcinoma patients. The endpoints of the study includes : overall survival, relapse free survival, distant metastasis and local-regional control rates. * To evaluate the toxicities of the two treatment methods.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin,5-FU,Leucovorin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- overall survival, relapse free survival,distant metastasis and local-regional control rates.
Secondary outcomes (1)
- measure
- toxicities of the two treatment methods.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically proven nasopharyngeal carcinoma who have just completed curative radiotherapy treatment. * Original stage must be stage IV disease (M0) * Patients must have a complete response, partial response or stable disease assessed 4 weeks after radiotherapy. * Performance status scale ECOG grade 0，1. * Creatinine ≦ 1.5mg/dl and bilirubin ≦ 2.0mg/dl, WBC ≧ 3,000/mm3 and PLT ≧ 100,000/mm3,or Creatinine Clearance \> 45ml/min if Creatinine \> 1.5mg/dl. * Patients must be younger than 70 year-old. * Patients must give signed informed consent. Exclusion Criteria: * Patients had progressive disease after radiotherapy * Patients had evidence of distant metastasis. * Patients had completed radiotherapy for more than 7 weeks. * The presence of life-threatening illness * History of prior malignancy excluding basal cell carcinoma or squamous carcinoma of the skin or in-situ cervical cancer within 3 years of the diagnosis of NPC cancer. * Previous chemotherapy. * Pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.