Erbitux Combined With Chemo-radiotherapy in Esophageal Squamous Cell Carcinoma (EXCEL)

This study has been completed.

Sponsor:

Collaborators:

Chinese Academy of Medical Sciences

Beijing Cancer Hospital

Hebei Fourth Hospital

Jiangsu Cancer Institute & Hospital

RenJi Hospital

The Affiliated Cancer Hospital of Zhengzhou University

West China Hospital

Information provided by:

Shandong Cancer Hospital and Institute

ClinicalTrials.gov Identifier:

NCT00815308

First received: December 29, 2008

Last updated: February 4, 2011

Last verified: July 2009

History of Changes

Results First Received: October 15, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Esophageal Cancer
Interventions:	Drug: cetuximab (Erbitux) Drug: Paclitaxel Drug: Cisplatin Radiation: Radiation

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Cetuximab, Concurrent Chemo-radiotherapy	Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8

Baseline Measures

	Cetuximab, Concurrent Chemo-radiotherapy
Number of Participants [units: participants]	55
Age [units: participants]
<=18 years	0
Between 18 and 65 years	46
>=65 years	9
Age [units: years] Mean ± Standard Deviation	57.68 ± 6.93
Gender [units: participants]
Female	10
Male	45
Region of Enrollment [units: participants]
China	55

Outcome Measures

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1. Primary:

Number of Participants With Overall Response Rate (RR) [ Time Frame: 1 to 3 month after therapy ]

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2. Secondary:

Number of Participants With Toxicity [ Time Frame: Every week during treatment and 1 month after therapy ]

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3. Secondary:

Number of Participants With K-ras Gene Mutation [ Time Frame: 07/29/2010-09/30/2010 ]

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4. Secondary:

Participants With Overall Survival (OS) at 1 Year [ Time Frame: 1 year from the date of diagnosis ]

Results not yet posted. Anticipated Posting Date: 08/2011 Safety Issue: No

5. Secondary:

Participants With Overall Survival (OS) at 3 Year [ Time Frame: 3 year from the date of diagnosis ]

Results not yet posted. Anticipated Posting Date: 08/2013 Safety Issue: No

6. Secondary:

Participants With Progression Free Survival (PFS) [ Time Frame: Recurrence or metastasis from the date of diagnosis ]

Results not yet posted. Anticipated Posting Date: 08/2013 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 NOT 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.

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: Jinming Yu
Organization: Shandong Cancer Hospital and Institute
phone: 86-531-87984729
e-mail: jn7984729@public.jn.sd.cn

Publications of Results:

Urba SG, Orringer MB, Turrisi A, Iannettoni M, Forastiere A, Strawderman M. Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol. 2001 Jan 15;19(2):305-13.

Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84.

Bosset JF, Gignoux M, Triboulet JP, Tiret E, Mantion G, Elias D, Lozach P, Ollier JC, Pavy JJ, Mercier M, Sahmoud T. Chemoradiotherapy followed by surgery compared with surgery alone in squamous-cell cancer of the esophagus. N Engl J Med. 1997 Jul 17;337(3):161-7.

Walsh TN, Noonan N, Hollywood D, Kelly A, Keeling N, Hennessy TP. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15;335(7):462-7. Erratum in: N Engl J Med 1999 Jul 29;341(5):384.

Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8.

Raben D, Helfrich B, Bunn PA Jr. Targeted therapies for non-small-cell lung cancer: biology, rationale, and preclinical results from a radiation oncology perspective. Int J Radiat Oncol Biol Phys. 2004;59(2 Suppl):27-38. Review.

Langer CJ. Emerging role of epidermal growth factor receptor inhibition in therapy for advanced malignancy: focus on NSCLC. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):991-1002. Review.

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.

Responsible Party:	Jinming Yu, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:	NCT00815308 History of Changes
Other Study ID Numbers:	SDRTC-0901
Study First Received:	December 29, 2008
Results First Received:	October 15, 2010
Last Updated:	February 4, 2011
Health Authority:	China: Ethics Committee China: Food and Drug Administration

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