Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy (ENCORE)

This study has been completed.

Sponsor:

Collaborators:

Cancer Institute Hospital, Chinese Academy of Medical Sciences

Sichuan Cancer Hospital and Research Institute

Fujian Provincial Cancer Hospital

Fudan University

Cancer Hospital of Guizhou Province

Guangxi Medical University

Central South University

Information provided by:

Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT00700440

First received: June 17, 2008

Last updated: March 9, 2010

Last verified: February 2009

History of Changes

Results First Received: January 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Nasopharyngeal Carcinoma
Intervention:	Drug: C225 (cetuximab)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
2008-7-1 ~ 2009-4-3

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Cetuximab	400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy

Participant Flow: Overall Study

	Cetuximab
STARTED	100
COMPLETED	100
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Cetuximab	400mg/m^2 intravenous infusion one week before radiotherapy, then 250mg/m^2 intravenous infusion weekly during radiotherapy

Baseline Measures

	Cetuximab
Number of Participants [units: participants]	100
Age [units: participants]
<=18 years	0
Between 18 and 65 years	100
>=65 years	0
Age [units: Years] Median ( Full Range )	43 ( 18 to 65 )
Gender [units: participants]
Female	74
Male	26
Region of Enrollment [units: participants]
China	100

Outcome Measures

1. Primary:

3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy [ Time Frame: 3 months ]

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2. Secondary:

1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival [ Time Frame: 5 year ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Dr. Lu Tai-xiang
Organization: Cancer Center, Sun Yat-sen University
phone: 86-20-87343372
e-mail: lutx@mail.sysu.edu.cn

Publications:

Sung FL, Poon TC, Hui EP, Ma BB, Liong E, To KF, Huang DP, Chan AT. Antitumor effect and enhancement of cytotoxic drug activity by cetuximab in nasopharyngeal carcinoma cells. In Vivo. 2005 Jan-Feb;19(1):237-45.

Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78.

Kiss R, Salmon I, Pauwels O, Gras S, Danguy A, Etievant C, Pasteels JL, Martinez J. In vitro influence of gastrin, oestradiol and gonadotropin-releasing hormone on HCT-15 and LoVo human colorectal neoplastic cell proliferation. Eur J Cancer. 1991;27(10):1268-74.

Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. Erratum in: J Clin Oncol. 2006 Feb 1;24(4):724.

Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. Erratum in: J Clin Oncol. 2007 Aug 20;25(24):3790.

Responsible Party:	Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00700440 History of Changes
Other Study ID Numbers:	EMR62202-770, PPRA-RTOG 0001
Study First Received:	June 17, 2008
Results First Received:	January 11, 2010
Last Updated:	March 9, 2010
Health Authority:	China: Ethics Committee China: Ministry of Health China: Food and Drug Administration

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