Clinical trial · Interventional
Chemoradiotherapy for Patients With Locally Advanced Nasopharyngeal Carcinoma Using Raltitrexed-Cisplatin
Study Of Induction Chemotherapy Followed by Concurrent Chemoradiotherapy With Raltitrexed-Cisplatin for Patients With Locally Advanced Nasopharyngeal Carcinoma
NCT02562599CI-TRIAL-00056664completedPhase 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 purpose of this study is to evaluate the efficacy and safety of raltitrexed and cisplatin neoadjuvant chemotherapy followed by concurrent radiotherapy with raltitrexed and cisplatin in patients with locally 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-modulated radiotherapy (IMRT) | Radiation | — | UNRESOLVED |
| raltitrexed-cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- drug:raltitrexed safety and efficacy
- description
- To receive the safety and efficacy of raltitrexed-cisplatin neoadjuvant chemotherapy followed by concurrent chemoradiotherapy with raltitrexed-cisplatin Interventions: Neochemotherapy (Induction Chemotherapy) Drugs: raltitrexed-cisplatin (Raltitrexed, 2.5mg/m2, IV in 15 minutes, d1; Cisplatin, 25mg/m2, IV, d1-3.Cycled every 21 days for 2 cycles). Concurrent Chemotherapy Drugs: raltitrexed-cisplatin (Raltitrexed, 2.5mg/m2, IV in 15 minutes, d1; Cisplatin, 25mg/m2, IV, d1-3.Cycled every 21 days for 2 cycles) . Radiation: Intensity-modulated radiotherapy (IMRT)
- interventionNames
- Drug: raltitrexed-cisplatin
- Radiation: Intensity-modulated radiotherapy (IMRT)
Primary outcomes (1)
- measure
- ORR (Objective Response Rate)
- timeFrame
- up to 12 weeks
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO III 2. Newly diagnosed T3-4 or any TN2-3 locally advanced nasopharyngeal carcinoma 3. At least one measurable lesion (according to the RECIST1.1) 4. female and male,18-70 years of age 5. ECOG performance status of 0-1 6. Life expectancy of more than 3 months 7. Without radiotherapy or chemotherapy 8. Adequate organ function including the following: Platelets count \>= 100 \* 109/l Absolute neutrophil count (ANC) \>= 2.0 \* 109/l Hemoglobin \>= 90 g/l Total bilirubin \<= 1.5ULN AST and ALT \<= 2.5ULN,if there is liver metastasis , AST and ALT \<= 5ULN Serum creatine \<= 1.5ULN 9. Signed and dated informed consent. Exclusion Criteria: 1. Before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix 2. Evidence of distant metastasis 3. Taboos of chemotherapy or radiotherapy(such as heart failure, angina pectoris, or cardiac arrhythmia.et al) Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia 4. Pregnant or breast-feeding females 5. Abuse of psychiatric drugs or dysphrenia 6. Prior chemotherapy with raltitrexed or cisplatin 7. Allergic to clinical drugs 8. Participation in clinical trials for other anti-tumor drugs in 4 weeks 9. Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
References
Publications (0)
Data not yet available
No reference posted for this study.