The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187238
• Other study ID #: CH-HN-001
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: October 2017

Study information

• Verified date: July 2020
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 2017
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• cisplatin
in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7

Locations

Country	Name	City	State
China	Cancer hospital, Chinese Academy of Medical Sciences	Beijing
China	Cancer hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Zhejiang province cancer hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicities	Acute toxicity will be measured by CTCAE3.0	2 years
Secondary	Long term treatment results	1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed.	5 years