Clinical trial · Interventional
Reduced-dose Versus Standard Dose Radiotherapy for Nasopharyngeal Carcinomain
Phase III Randomized Non-inferiority Trial of Reduced-dose Versus Standard Dose Radiotherapy for Stage II-III Nasopharyngeal Carcinoma Which Have Favorable Response After Induction Chemotherapy
NCT05304468CI-TRIAL-00087525active not recruitingPhase 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)
To study the 2-year PFS (progression-free survival) of patients with stage II-III nasopharyngeal carcinoma treated with induction chemotherapy followed by two different doses of intensity modulated radiation therapy plus concurrent cisplatin chemotherapy
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin concurrent chemotherapy | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
| induction chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Reduced-dose group
- description
- After 2 cycles of induction chemotherapy, patients with favorable response undergo low-dose (60Gy) intensity-modulated radiotherapy (IMRT) 5 days per week for approximately 6 weeks (30 fractions). Patients also receive concurrent cisplatin once every three weeks for 2 cycles.
- interventionNames
- Radiation: IMRT
- Drug: induction chemotherapy
- Drug: cisplatin concurrent chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Standard dose group
- description
- After 2 cycles of induction chemotherapy, patients with favorable response undergo standard-dose (70Gy) intensity modulated radiotherapy (IMRT) 5 days per week for approximately 7 weeks (33 fractions). Patients also receive concurrent cisplatin once every three weeks for 3 cycles.
- interventionNames
- Radiation: IMRT
- Drug: induction chemotherapy
- Drug: cisplatin concurrent chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients newly diagnosed with histologically confirmed non-keratinizing NPC (WHO type II or III). 2. Stage II-III（8thAJCC/UICC staging system) 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\<1.5 x ULN；TBIL\<1.5×ULN 7. CCR≥60ml/min or Cr\<1.5×ULN 8. CR/PR and EBVDNA undetectable after induction chemotherapy 9. 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 (0)
Data not yet available
No reference posted for this study.