Clinical trial · Interventional
Two Cycles Versus Three Cyclle of CCRT for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma
A Randomized Phase II Non-inferiority Study of Two Cycles Versus Three Cycles of Cisplatin Based Concurrent Chemoradiotherapy for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma Based on Pretreatment Plasma EBV DNA Level
NCT02871518CI-TRIAL-00024770unknownPhase 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)
This is a Phase II trial to study the effectiveness of two cycles versus three cycles of Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin combine with IMRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Two cycle CCRT
- description
- Concurrent cisplatin(100mg/m2,D1,D22)combine with IMRT
- interventionNames
- Drug: Cisplatin combine with IMRT
- type
- ACTIVE_COMPARATOR
- label
- Three cycle CCRT
- description
- Concurrent cisplatin(100mg/m2,D1,D22 and D43)combine with IMRT
- interventionNames
- Drug: Cisplatin combine with IMRT
Primary outcomes (1)
- measure
- Progress-free survival
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III * Original clinical staged as T3-4N0-3 M0 or any T、N2-3M0（according to the 7th AJCC edition） * No evidence of distant metastasis (M0) * Pretreatment Plasm EB Virus DNA\<4000copies/ml * Male and no pregnant female * Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1 * WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L * With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN) * With normal renal function test (Creatinine ≤ 1.5×ULN) Exclusion Criteria: * Patients have evidence of relapse or distant metastasis * Histologically confirmed keratinizing squamous cell carcinoma (WHO I) * Receiving radiotherapy or chemotherapy previously * The presence of uncontrolled life-threatening illness * Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. * Receiving other ways of anti-cancer therapy. * Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
References
Publications (2)
- DERIVEDLi YC, Li XY, Lan KQ, Cheng H, Chen J, Liu LT, Wen DX, Gu LW, Guo WP, Sun XS, Liu SL, Yang JH, Li SC, Li YF, Long HX, Luo DH, Guo L, Mo HY, Sun R, Guo SS, Wang P, Li LB, Yang Q, Liang YJ, Jia GD, Yan JJ, Zhao C, Chen QY, Li LJ, Mai HQ, Tang LQ. Epstein-Barr virus DNA-guided chemoradiotherapy for patients with low-risk locoregionally advanced nasopharyngeal carcinoma: a secondary 5-year follow-up analysis of an open-label, randomised controlled, phase 2 non-inferiority trial. EClinicalMedicine. 2025 Oct 30;90:103615. doi: 10.1016/j.eclinm.2025.103615. eCollection 2025 Dec. PMID 41245547
- DERIVEDLi XY, Luo DH, Guo L, Mo HY, Sun R, Guo SS, Liu LT, Yang ZC, Yang JH, Qiu F, Sun XS, Wang P, Liu Q, Li JB, Tang QN, Lin C, Yang Q, Liu SL, Liang YJ, Jia GD, Wen DX, Guo CY, Yan JJ, Zhao C, Chen QY, Tang LQ, Mai HQ. Deintensified Chemoradiotherapy for Pretreatment Epstein-Barr Virus DNA-Selected Low-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II Randomized Noninferiority Trial. J Clin Oncol. 2022 Apr 10;40(11):1163-1173. doi: 10.1200/JCO.21.01467. Epub 2022 Jan 6. PMID 34990291