Clinical trial · Observational
GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Distant Metastatic Nasopharyngeal Carcinoma
Prospective Phase II Clinical Study of GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Nasopharyngeal Carcinoma
NCT03723343CI-TRIAL-00035508unknownClinicalTrials.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)
Mainly compared with GP induction chemotherapy combined with IMRT and TPF induction chemotherapy combined with IMRT in the treatment of nasopharyngeal carcinoma, the cure rate, remission rate, treatment of distant metastases and lymph node metastasis, quality of life improvement rate, etc.
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 |
|---|---|---|---|
| Advanced Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GP+IMRT | Drug | — | UNRESOLVED |
| TPF+IMRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Experimental: GP+IMRT
- description
- Test group: GP-induced chemotherapy (Gemcitabine 1000 mg/m2 d1, 8+Cisplatin 80 mg/m2 d1, once every 3 weeks, 4/6 course) + IMRT radiotherapy alone
- interventionNames
- Drug: GP+IMRT
- label
- Active Comparator: TPF+IMRT
- description
- Control group: TPF-induced chemotherapy (Docetaxel: 75 mg/m2d1, Cisplatin 75 mg/m2, d1\~d5, 5-fluorouracil 750 mg/m2/dd1\~d5, 4/6 course) + IMRT radiotherapy alone
- interventionNames
- Drug: TPF+IMRT
Primary outcomes (1)
- measure
- Progress-free survival(PFS)
- timeFrame
- 3 years
- description
- Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. The pathological type is non-keratinized cancer (according to the pathological classification of the World Health Organization, WHO). 2. The stage is TxNxM1 (according to the eighth edition of the AJCC staging standard) (Appendix I). 3. There is evidence of distant transfer (M1). 4. functional status: Karnofsky scale (KPS) \> 70 (Appendix II). 5. normal bone marrow function: white blood cell count \> 4 × 109 / L, hemoglobin \> 90g / L and platelet count \> 100 × 109 / L. 6. normal liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \<1.5 times the upper limit of normal (ULN), and alkaline phosphatase (alkaline phosphatase, ALP) \< 2.5 x ULN and bilirubin \< ULN. 7. normal renal function: creatinine clearance (creatinine clearance) \> 60 ml / min. 8. The patient must be informed of the basic content of the study and sign an informed consent form. \- Exclusion Criteria: 1. the pathological type is WHO keratinized squamous cell carcinoma or basal squamous cell carcinoma. 2. age \> 65 years old or \< 18 years old. 3. a history of malignant tumors, except for adequately treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ. 4. Women during pregnancy or lactation (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasized during treatment). 5. has received radiation therapy (if it is non-melanoma skin cancer and the previous lesion is placed Except for the target area of treatment. 6. primary lesions and cervical metastases have received chemotherapy or surgery (except for diagnostic treatment). 7. accompanied by other serious diseases, may bring greater risk or affect the compliance of the test. For example: unstable heart disease, kidney disease, chronic hepatitis, uncontrolled diabetes (fasting blood glucose \> 1.5 x ULN), and mental illness. -
References
Publications (0)
Data not yet available
No reference posted for this study.