Clinical trial · Interventional
Optimized Treatment Strategies for Early and Medium Stage Nasopharyngeal Carcinoma
A Randomized Multicenter Phase II/III Study of Optimized Treatment Strategies for Stage II and III Nasopharyngeal Carcinoma
NCT03908372CI-TRIAL-00049717unknownPhase 2 / Phase 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 optimize treatment strategies for patients with stage II and III nasopharyngeal carcinoma, reduce the side effects related to treatment and improve the quality of life.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Concurrent Chemoradiotherapy | — | UNRESOLVED | — |
| Induction Chemotheray | — | UNRESOLVED | — |
| Nasopharyngeal Squamous Cell Carcinoma | Nasopharyngeal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Reduce Treatment Intensity | — | UNRESOLVED | — |
| Stage II, III | — | UNRESOLVED | — |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy(IC)+IMRT
- description
- Induction chemotherapy for two cycles, the patients with complete response will receive 60 Gy to the gross target volume of nasopharynx, partial response 64 Gy, and the absence of response will receive concurrent chemoradiotherapy as the same as CCRT arm
- interventionNames
- Drug: Docetaxel
- Drug: Cisplatin
- Radiation: IMRT
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoradiotherapy(CCRT)
- description
- cisplatin 100mg/m2 IV on d1 of each 21 days for two cycles at least and 70 Gy radiotherapy
- interventionNames
- Drug: Cisplatin
- Radiation: IMRT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathology confirmed nasopharyngeal squamous cell carcinoma. * Aged 18 to 70 years old; * Stage II-III (T1N1M0，T2-3N0-1M0) diseases according to 8th AJCC Staging and the shortest diameter of the largest lymph node involved is no more than 3cm; * KPS≥70; * Have measurable lesions on CT/MRI before treatment; * Treatment for the first time; * At least 6 months lifetime was expected; * Adequate laboratory indexes, defined as follows: Hemoglobin \> 120g/L, WBC \> 4.0x10\*9/L, Plt \> 100x10\*9/L \< 2, all indexes of liver and kidney function ≤ 1.25 times of the institutional upper limit of normal value, no hearing loss; * Can understand and sign the consent * Have follow up condition Exclusion Criteria: * Past malignancies history (except for stage I non-melanoma skin cancer or cervical carcinoma in situ) * Previously treatment for cancer * Pregnant or breeding woman, female without contraception * Enrolling in other drug trials * Severe comorbidities including myocardial infarction, arrhythmia, cerebral vascular disease, ulceration disease, mental disease and uncontrolled diabetes * Without follow up
References
Publications (4)
- BACKGROUNDXu C, Sun R, Tang LL, Chen L, Li WF, Mao YP, Zhou GQ, Guo R, Lin AH, Sun Y, Ma J, Hu WH. Role of sequential chemoradiotherapy in stage II and low-risk stage III-IV nasopharyngeal carcinoma in the era of intensity-modulated radiotherapy: A propensity score-matched analysis. Oral Oncol. 2018 Mar;78:37-45. doi: 10.1016/j.oraloncology.2018.01.008. Epub 2018 Feb 20. PMID 29496056
- BACKGROUNDLiu YC, Wang WY, Twu CW, Jiang RS, Liang KL, Lin PJ, Lin JW, Lin JC. Comparison Long-term Outcome of Definitive Radiotherapy plus Different Chemotherapy Schedules in Patients with Advanced Nasopharyngeal Carcinoma. Sci Rep. 2018 Jan 11;8(1):470. doi: 10.1038/s41598-017-18713-z. PMID 29323141
- BACKGROUNDYao JJ, Yu XL, Zhang F, Zhang WJ, Zhou GQ, Tang LL, Mao YP, Chen L, Ma J, Sun Y. Radiotherapy with neoadjuvant chemotherapy versus concurrent chemoradiotherapy for ascending-type nasopharyngeal carcinoma: a retrospective comparison of toxicity and prognosis. Chin J Cancer. 2017 Mar 6;36(1):26. doi: 10.1186/s40880-017-0195-6. PMID 28264724
- BACKGROUNDXu C, Zhang LH, Chen YP, Liu X, Zhou GQ, Lin AH, Sun Y, Ma J. Chemoradiotherapy Versus Radiotherapy Alone in Stage II Nasopharyngeal Carcinoma: A Systemic Review and Meta-analysis of 2138 Patients. J Cancer. 2017 Jan 15;8(2):287-297. doi: 10.7150/jca.17317. eCollection 2017. PMID 28243333