Clinical trial · Interventional
The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma
A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma
NCT01187238CI-TRIAL-00045992completedPhase 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)
The purpose of this study is to verify the role of adding cisplatin chemotherapy to the intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.
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 | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm1-radical radiotherapy alone group
- description
- Arm1-radical radiotherapy alone group, the eligibility patients will received radical intensity-modulated radiotherapy alone
- type
- EXPERIMENTAL
- label
- Arm2-concurrent chemoradiotherapy group
- description
- Arm2-concurrent chemoradiotherapy group, the eligibility patients will received radiotherapy the same as radical radiotherapy arm,and also will received the concurrent chemotherapy wiht the regimen consist of cisplatin 40mg/m2, weekly for 7weeks.
- interventionNames
- Drug: cisplatin
Primary outcomes (1)
- measure
- Acute toxicities
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * pathological confirmed squamous cell carcinoma, WHO II-III type, * clinical stage II (UICC 7th edition, 2009) * Karnovsky performance score \> 70 * first course of radiotherapy, without radiotherapy and chemotherapy history for other head and neck cancer. * anticipated life span more than 6 month * Hemoglobin \> 120g/L, WBC \> 4.0x10\*9/L, Plt \> 100x10\*9/L * liver and renal function under the 1.25 normal upper limit * with written consent information Exclusion Criteria: * have other cancer history * have chemotherapy history * have radiotherapy history * have head and neck surgery history(exclusion lymph node biopsy) * evidence showed distant metastasis or other cancer * other severe medical comorbidity
References
Publications (5)
- BACKGROUNDKam MK, Leung SF, Zee B, Chau RM, Suen JJ, Mo F, Lai M, Ho R, Cheung KY, Yu BK, Chiu SK, Choi PH, Teo PM, Kwan WH, Chan AT. Prospective randomized study of intensity-modulated radiotherapy on salivary gland function in early-stage nasopharyngeal carcinoma patients. J Clin Oncol. 2007 Nov 1;25(31):4873-9. doi: 10.1200/JCO.2007.11.5501. PMID 17971582
- BACKGROUNDChua DT, Sham JS, Kwong DL, Au GK. Treatment outcome after radiotherapy alone for patients with Stage I-II nasopharyngeal carcinoma. Cancer. 2003 Jul 1;98(1):74-80. doi: 10.1002/cncr.11485. PMID 12833458
- RESULTChua DT, Ma J, Sham JS, Mai HQ, Choy DT, Hong MH, Lu TX, Au GK, Min HQ. Improvement of survival after addition of induction chemotherapy to radiotherapy in patients with early-stage nasopharyngeal carcinoma: Subgroup analysis of two Phase III trials. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1300-6. doi: 10.1016/j.ijrobp.2006.02.016. Epub 2006 Jun 5. PMID 16750333
- RESULTCheng SH, Tsai SY, Yen KL, Jian JJ, Chu NM, Chan KY, Tan TD, Cheng JC, Hsieh CY, Huang AT. Concomitant radiotherapy and chemotherapy for early-stage nasopharyngeal carcinoma. J Clin Oncol. 2000 May;18(10):2040-5. doi: 10.1200/JCO.2000.18.10.2040. PMID 10811668
- DERIVEDHuang X, Chen X, Zhao C, Wang J, Wang K, Wang L, Miao J, Cao C, Jin T, Zhang Y, Qu Y, Chen X, Liu Q, Zhang S, Zhang J, Luo J, Xiao J, Xu G, Gao L, Yi J. Adding Concurrent Chemotherapy to Intensity-Modulated Radiotherapy Does Not Improve Treatment Outcomes for Stage II Nasopharyngeal Carcinoma: A Phase 2 Multicenter Clinical Trial. Front Oncol. 2020 Aug 7;10:1314. doi: 10.3389/fonc.2020.01314. eCollection 2020. PMID 32850414