Clinical trial · Interventional
Comparison the Effects of Different Neoadjuvant Chemotherapy Regimen on Acute Toxicity, Tumor Response, and Survival in Patients With Advanced Nasopharyngeal Carcinoma
NCT02500940CI-TRIAL-00018574unknownPhase 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)
The purpose of this study is to investigate the impact of different neoadjuvant chemotherapy schedules of cisplatin and 5-FU on acute toxicity, tumor response, and long-term survival in patients with advanced nasopharyngeal carcinoma
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Control group
- description
- Neoadjuvant chemotherapy with tri-weekly cisplatin plus fluorouracil × 3 cycles (cisplatin 100 mg/m2, day 1, followed by fluorouracil 1000 mg/m2/d, days 1-4 continuous iv infusion, repeated every 3 weeks) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions
- interventionNames
- Drug: Cisplatin
- Drug: Fluorouracil
- Radiation: Radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Test group
- description
- Neoadjuvant chemotherapy with weekly cisplatin, fluorouracil and leucovorin × 10 weeks (cisplatin 60 mg/m2 at days 1, 15, 29, 43, 57; alternatively with fluorouracil 2500 mg/m2 + leucovorin 250 mg/m2 at days 8, 22, 36, 50, 64) + Intensity-Modulated Radiation Therapy ≧ 70 Gy/35 fractions
- interventionNames
- Drug: Cisplatin
- Drug: Fluorouracil
- Radiation: Radiation therapy
- Drug: Leucovorin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histological proven NPC. 2. 2010 AJCC stage II-IVB. 3. Age ≧ 20 years old. 4. Performance status of ECOG ≦ 2. 5. Adequate liver, renal, and bone marrow functions 5-1 Serum total bilirubin level ≦ 2.5 mg/dl. 5-2 Serum creatinine ≦ 1.6 mg/dl or calculated CCr ≧ 60 cc/min. 5-3 WBC ≧ 3,000/ul 5-4 Platelet count ≧ 100,000/ul 6. Signed informed consent. Exclusion Criteria: 1. Presence of distant metastasis. 2. Previous radiotherapy or chemotherapy. 3. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast. 4. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders. 5. Female patients who are pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.