Clinical trial · Interventional
Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial
NCT05979961CI-TRIAL-00121586active 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)
The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).
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 |
|---|---|---|---|
| gemcitabine and cisplatin (Induction chemotherapy) | Drug | — | UNRESOLVED |
| IMRT and concurrent cisplatin | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMRT and concurrent cisplatin
- description
- Patients receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
- interventionNames
- Radiation: IMRT and concurrent cisplatin
- type
- ACTIVE_COMPARATOR
- label
- Induction chemotherapy+IMRT and concurrent cisplatin
- description
- Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
- interventionNames
- Radiation: IMRT and concurrent cisplatin
- Drug: gemcitabine and cisplatin (Induction chemotherapy)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-70 years old. 2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). 3. Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml. 4. ECOG Performance status less or equal to 1. 5. Male and no pregnant female. 6. Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. 7. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \< 2.5×ULN, and bilirubin \< ULN. 8. Adequate renal function: creatinine clearance ≥ 60 ml/min. 9. Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: 1. Patients have evidence of relapse or distant metastasis. 2. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 3. Treatment with palliative intent. 4. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). 5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. 6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). 7. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 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.