Clinical trial · Interventional
Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)
Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
- 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 response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) 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,IVa, IVb NPC treated with this regimen. The third objective of this study is to evaluate who may benifit from this treatment 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) | Radiation | — | UNRESOLVED |
| docetaxel, cisplatin, fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.
- interventionNames
- Drug: docetaxel, cisplatin, fluorouracil
- Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 3 and 5 years
Secondary outcomes (1)
- measure
- distant metastases free survival , and disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx. * Stage Ⅲ, IVa and IVb 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. * the primary tumor or involved lymph node must be more than 2CM in diameter. * 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)
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