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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overOther200803088M
NCT01034189

Trial Description

Summary

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).

Further Study Information

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 Criteria

Inclusion Criteria:

1. Pathologically proven squamous cell carcinoma of esophagus.

2. 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.

3. Age ≥ 18 years old.

4. Performance status ECOG 0~2.

5. 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.

6. 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).

7. Adequate renal function: Creatinine ≤1.5 mg/dl

8. Written informed consent.

Exclusion Criteria:

1. Invasion to surrounding organ (T4 disease).

2. Distant metastasis, except M1a disease listed in the inclusion criteria 2-C.

3. Adenocarcinoma of gastroesophageal (GE) junction.

4. Prior thoracic irradiation.

5. Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.

6. 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.

7. 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.

8. Estimated life expectancy less than 3 months.

Trial Contact Information

Trial Lead Organizations/Sponsors

National Taiwan University Hospital

Yung-Chie Lee, M.D.Principal Investigator

Chih-Hung Hsu, M.D., Ph.D.Ph: 886-2-23123456 Ext.67680
  Email: chihhunghu@ntu.edu.tw

Trial Sites

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

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01034189
ClinicalTrials.gov processed this data on October 20, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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