Clinical trial · Interventional
Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ Nasopharyngeal Carcinoma
NCT00816855CI-TRIAL-00001865unknownPhase 2ClinicalTrials.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 primary objective of this study is to determine the tolerance and overall survival in patients with stage Ⅲ NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation. Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage Ⅲ treated with this regimen.
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 |
|---|---|---|---|
| docetaxel, cisplatin, fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of three cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
- interventionNames
- Drug: docetaxel, cisplatin, fluorouracil
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 3 and 5 years
Secondary outcomes (1)
- measure
- distant metastases free survival , and disease-free survival
- timeFrame
- 3 and 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx. * Stage Ⅲ disease * KPS \>70 * Age between 18-70 * Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). Bilirubin \< 1.5 mg/dl, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min. * No prior radiation treatment to the head and neck or any prior chemotherapy * Patients with no prior malignancy (not include basal cell carcinoma of skin) Exclusion Criteria: * Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. * Prior radiotherapy to the head and neck region for any reason. * Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. * Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. * Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.