Clinical trial · Interventional
Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma
A Phase II Trial of Induction Chemotherapy Followed by Cisplatin With Low Dose vs. Standard Dose IMRT in Stage III Nasopharyngeal Carcinoma Patients With Pretreatment EBV DNA<4000 Copy/ml
NCT03668730CI-TRIAL-00053480unknownPhase 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)
To study the 2-year PFS (progression-free survival) of patients with stage III nasopharyngeal carcinoma of pretreatment EBV DNA\<4000 copy/ml treated with induction chemotherapy followed by two different doses of intensity-modulated radiation therapy and cisplatin.
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 |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Intensity-modulated radiation therapy | Radiation | — | UNRESOLVED |
| Paclitaxel liposome | Drug | Paclitaxel Liposome | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reduced dose group
- description
- After 2 cycles of induction chemotherapy with Paclitaxel Liposome, Cisplatin and 5-Fluorouracil, patients undergo low-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive cisplatin once per three week for 3 cycles.
- interventionNames
- Radiation: Intensity-modulated radiation therapy
- Drug: Paclitaxel liposome
- Drug: Cisplatin
- Drug: 5-Fluorouracil
- type
- EXPERIMENTAL
- label
- Standard dose group
- description
- After 2 cycles of induction chemotherapy with Paclitaxel Liposome,Cisplatin and 5-Fluorouracil, patients undergo standard-dose intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (33 fractions). Patients also receive cisplatin once per three week for 3 cycles.
- interventionNames
- Radiation: Intensity-modulated radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathological diagnosis of NPC(WHO II or III). 2. Stage III(8thAJCC/UICC staging system) and pretreatment EBVDNA\<4000opies/ml. 3. Aged 18-70 years。 4. ECOG = 0-1。 5. HGB≥90 g/L,WBC≥4×109 /L,PLT≥100×109 /L. 6. ALT,AST\<2.5 fold of ULN;TBIL\<2.0×ULN。 7. CCR≥60ml/min or Cr\<1.5×ULN。 8. Signed informed consent Exclusion Criteria: 1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. Age \<18 or \>70years. 3. Treatment with palliative intent. 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 5. Pregnancy or lactation. 6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). 7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
References
Publications (1)
- DERIVEDGuo SS, Yang JH, Sun XS, Liu LZ, Yang ZC, Liu LT, Liu SL, Li XY, Lv XF, Luo DH, Li JB, Liu Q, Wang P, Guo L, Mo HY, Sun R, Yang Q, Liang YJ, Jia GD, Zhao C, Chen QY, Tang LQ, Mai HQ. Reduced-dose radiotherapy for Epstein-Barr virus DNA selected staged III nasopharyngeal carcinoma: A single-arm, phase 2 trial. Eur J Cancer. 2023 Nov;194:113336. doi: 10.1016/j.ejca.2023.113336. Epub 2023 Sep 9. PMID 37801967