Clinical trial · Interventional
Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
NCT03015727CI-TRIAL-00025420IRCNPCunknownPhase 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)
In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).
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 |
|---|---|---|---|
| Locally Advanced Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| IMRT/TOMO | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IC+RT group
- description
- 3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Radiation: IMRT/TOMO
- type
- ACTIVE_COMPARATOR
- label
- IC+CCRT group
- description
- 3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Radiation: IMRT/TOMO
- Drug: Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing carcinoma. 2. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system) 3. No evidence of distant metastasis (M0) 4. Performance status: KPS\>70 5. With normal liver function test (ALT, AST \<1.5ULN) 6. Renal: creatinine clearance \>60ml/min 7. Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L. 8. With controlled blood glucose for diabetes patients 9. Written informed consent 10. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) Exclusion Criteria: 1. WHO type I squamous cell carcinoma or adenocarcinoma 2. Age \>65 or \<18 3. With a history of renal disease 4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin) 5. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) 6. Patient is pregnant or lactating 7. Peripheral neuropathy 8. Emotional disturbance
References
Publications (1)
- DERIVEDJin T, Jiang F, Jin QF, Hua YH, Jia YS, Du DX, Ding SB, Su HF, Lu MZ, He HJ, Chen XZ. Randomized, multicenter phase 3 study evaluating radiotherapy versus concurrent chemoradiotherapy in nasopharyngeal carcinoma patients achieving CR/PR after induction chemotherapy. BMC Med. 2026 Jul 11. doi: 10.1186/s12916-026-05064-8. Online ahead of print. PMID 42436536