The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nasopharyngeal Carcinoma	Drug: cisplatin	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:

Acute toxicities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Acute toxicity will be measured by CTCAE3.0

Secondary Outcome Measures:

Long term treatment results [ Time Frame: 5 years ] [ Designated as safety issue: No ]
1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed.

Estimated Enrollment:	80
Study Start Date:	July 2010
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Arm1-radical radiotherapy alone group Arm1-radical radiotherapy alone group, the eligibility patients will received radical intensity-modulated radiotherapy alone
Experimental: Arm2-concurrent chemoradiotherapy group 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.	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 Other Name: DDP

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187238

Contacts

Contact: Junlin Yi, MD	861087788504	junlinyi@sohu.com
Contact: Xiaodong Huang, MD	861086350533	hxd010@gmail.com

Locations

China, Guangdong
Cancer hospital, Sun Yat-sen University	Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Chong zhao, MD +86113902206160 gzzhaochong@163.com
Principal Investigator: Chong Zhao, MD
China, Zhejiang
Zhejiang province cancer hospital	Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaozhong Chen, MD 8613505717886 cxzfyun@sina.com
Principal Investigator: Xiaozhong Chen, MD
China
Cancer hospital, Chinese Academy of Medical Sciences	Recruiting
Beijing, China, 100021
Contact: Junlin Yi, MD 861087788504 junlinyi@sohu.com
Contact: Xiongdong Huang, MD 861086350533 hxd010@gmail.com
Principal Investigator: Li Gao, MD

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

Principal Investigator:

Li Gao, MD

Cancer Hospital, Chinese Academy of Medical Sciences

More Information

Publications:

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. Epub 2006 Jun 5.

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.

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.

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.

Responsible Party:	Li Gao, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01187238 History of Changes
Other Study ID Numbers:	CH-HN-001
Study First Received:	August 18, 2010
Last Updated:	February 21, 2013
Health Authority:	China: Ministry of Health

Keywords provided by Chinese Academy of Medical Sciences:

Nasopharyngeal carcinoma
Stage II
Intensity-modulated radiotherapy
Concurrent chemoradiotherapy
Cisplatin

Additional relevant MeSH terms:

Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma

Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013