Cetuximab/Paclitaxel/Cisplatin Concurrent Chemoradiotherapy Followed by Esophagectomy for Loco-regional Esophageal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by National Taiwan University Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT01034189

First received: December 16, 2009

Last updated: NA

Last verified: December 2009

History: No changes posted

Purpose

We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy (TP-CCRT) as the adjunctive therapy before esophagectomy or as a definitive CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional esophageal squamous cell carcinoma (ESCC).

Condition	Intervention	Phase
Esophageal Cancer	Drug: Cetuximab Drug: Paclitaxel Drug: Cisplatin Radiation: Radiotherapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Combining Cetuximab Plus Twice Weekly Paclitaxel/Cisplatin Concurrent Chemoradiotherapy (TP-CCRT) Followed With or Without Esophagectomy for Loco-regional Esophageal Squamous Cell Carcinoma (ESCC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin Paclitaxel Cetuximab

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

To determine the clinical response rate in patients with loco-regional esophageal squamous cell carcinoma treated with cetuximab combined with twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy (C-TP-CCRT, 40 Gy). [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pathologic complete response (pCR). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Disease-free survival. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety and toxicity of cetuximab combined with twice weekly TP-CCRT, followed by surgery. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Targeted therapy Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy	Drug: Cetuximab Cetuximab: loading dose 400 mg/m2, 2h- IVF, 3~ 5 days prior to starting CCRT (on week-1); followed by 250 mg/m2/ week, 1h- IVF, for 4 weeks (i.e., week 1 to week 4. during CCRT). Other Name: Erbitux Drug: Paclitaxel T: Paclitaxel 35 mg/m2, 1h IVF, on day 1 and day 4 of each week, week1 to week4 during CCRT. Drug: Cisplatin P: Cisplatin 15 mg/m2, 1 h IVF, on day 2 and day 5 of each week, week1 to week4 during CCRT. Radiation: Radiotherapy Radiotherapy: (three-dimensional conformal radiotherapy or intensity modulated radiotherapy) 200 cGy/fraction, once daily, 5 days a week, to a total dose of 4000 cGy.

Arms

Assigned Interventions

Experimental: Targeted therapy

Concurrent chemoradiotherapy with cetuximab, paclitaxel, and cisplatin followed by, if feasible, esophagectomy

Drug: Cetuximab

Cetuximab: loading dose 400 mg/m2, 2h- IVF, 3~ 5 days prior to starting CCRT (on week-1); followed by 250 mg/m2/ week, 1h- IVF, for 4 weeks (i.e., week 1 to week 4. during CCRT).

Other Name: Erbitux

Drug: Paclitaxel

T: Paclitaxel 35 mg/m2, 1h IVF, on day 1 and day 4 of each week, week1 to week4 during CCRT.

Drug: Cisplatin

P: Cisplatin 15 mg/m2, 1 h IVF, on day 2 and day 5 of each week, week1 to week4 during CCRT.

Radiation: Radiotherapy

Radiotherapy: (three-dimensional conformal radiotherapy or intensity modulated radiotherapy) 200 cGy/fraction, once daily, 5 days a week, to a total dose of 4000 cGy.

Detailed Description:

We hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy as the adjunctive therapy before esophagectomy or as a definitive CRT would improve the therapeutic efficacy of TP-CCRT in patients with loco-regional esophageal squamous cell carcinoma.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pathologically proven squamous cell carcinoma of esophagus.
Loco-regional diseases, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (6th edition) in 2002, fulfilling one of the following criteria:

A. T3, N0, M0; B. T1-3, N1, M0; C. T1-3 or N0-1, M1a will be eligible provided the lesions could be covered by appropriate radiation fields.
Age ≥ 18 years old.
Performance status ECOG 0~2.
Adequate bone marrow reserves, defined as:

A. white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl; B. platelets ≥ 100,000/µl.
Adequate liver function reserves, defined as:

A. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); B. serum total bilirubin ≤ 1.5 x upper limit of normal (ULN).
Adequate renal function: Creatinine ≤1.5 mg/dl
Written informed consent.

Exclusion Criteria:

Invasion to surrounding organ (T4 disease).
Distant metastasis, except M1a disease listed in the inclusion criteria 2-C.
Adenocarcinoma of gastroesophageal (GE) junction.
Prior thoracic irradiation.
Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
Prior malignancy, except for the following:

A. adequately treated basal cell or squamous cell skin cancer; B. in-situ cervical cancer; C. Note: previously treated aerodigestive squamous cell carcinoma is not allowed.
Significant co-morbid disease, which prohibit the conduction of chemotherapy, concurrent chemoradiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
Estimated life expectancy less than 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034189

Contacts

Contact: Chih-Hung Hsu, M.D., Ph.D.

886-2-23123456 ext 67680

chihhunghu@ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 10002
Contact: Chih-Hung Hsu, M.D., Ph.D. 886-2-23123456 ext 67680 chihhunghsu@ntu.edu.tw
Principal Investigator: Chih-Hung Hsu, M.D., Ph.D.

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Yung-Chie Lee, M.D.

National Taiwan University Hospital

More Information

No publications provided

Responsible Party:	Chih-Hung Hsu / Department of Oncology, National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT01034189 History of Changes
Other Study ID Numbers:	200803088M
Study First Received:	December 16, 2009
Last Updated:	December 16, 2009
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Esophageal cancer
Chemoradiotherapy
Paclitaxel
Cetuximab

Additional relevant MeSH terms:

Carcinoma, Squamous Cell
Esophageal Diseases
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

Cetuximab
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 21, 2013

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