Clinical trial · Interventional
Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
NCT00817258CI-TRIAL-00001867unknownPhase 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 overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy. Secondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage II NPC 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy) | Radiation | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- description
- All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
- interventionNames
- Drug: cisplatin
- 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
- disease-free survival, and distant metastases 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 II disease (T1-2; N1; M0) * 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.