Clinical trial NCT01187238: The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma
Official title: A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
Stage II
Intensity-modulated radiotherapy
Concurrent chemoradiotherapy
Cisplatin
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2010-08-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three subgroups, the data came from conventional radiotherapy era showed that the prognosis of this three subgroups were different, the N1 groups suffered more distant metastasis than N0 group, and some literature showed that combined chemotherapy with radiotherapy in stage II patients can improve the treatment results.

Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality of life in nasopharyngeal through salivary gland preservation.

Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup) nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.

Eligibility criteria: 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

Primary outcomes:
measure: Acute toxicities
timeFrame: 2 years
Secondary outcomes:
measure: Long term treatment results
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer hospital, Sun Yat-sen University
state: Guangdong
city: Hangzhou
country: China
facility: Zhejiang province cancer hospital
state: Zhejiang
city: Beijing
country: China
facility: Cancer hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Li Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kam 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.
citation: Chua 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.
citation: Chua 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.
citation: Cheng 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.
citation: Huang 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.