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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00659113
Other study ID # CDR0000593402
Secondary ID YONSEI-4-2007-03
Status Recruiting
Phase Phase 2
First received April 15, 2008
Last updated December 3, 2011
Start date March 2008

Study information

Verified date December 2008
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy together with more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving S-1 and cisplatin together with radiation therapy works in treating patients with stage IIA, stage III, or stage IVA esophageal cancer that can be removed by surgery.


Description:

OBJECTIVES:

Primary

- To evaluate response rate in patients with stage IIA-IVA resectable esophageal cancer treated with chemoradiotherapy comprising S-1, cisplatin, and radiotherapy.

Secondary

- To evaluate overall survival of these patients.

- To evaluate progression-free survival of these patients.

- To evaluate toxicity in these patients.

- To correlate initial squamous cell carcinoma antigen and C-reactive protein with response and survival in these patients.

OUTLINE: Patients receive oral S-1 twice weekly, cisplatin IV over 2 hours on day 1, and undergo radiotherapy 5 days a week in weeks 1 and 2. Treatment repeats every 3 weeks for 2 courses.

Tumor tissue samples are collected by esophagoscopy with biopsy and brushings for analysis of initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival.

After completion of study treatment, patients are followed for 6 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed carcinoma of the esophagus

- Stage IIA-IVA disease

- Resectable disease

- Measurable disease, defined as at least 1 measurable lesion by RECIST criteria

- No known brain metastasis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy > 3 months

- ANC = 1,500/uL

- Hemoglobin = 9.0 g/dL (transfusion correction allowed)

- Platelets = 100,000/uL

- Creatinine < 1.5 mg/dL

- Total bilirubin < 2 times upper limit of normal (ULN)

- ALT/AST < 3 times ULN

- Fertile patients must use effective contraception

- Not pregnant or nursing

- Able to take oral medication

- No active peptic ulcer disease

- No known hypersensitivity to study drugs

- No serious uncontrolled systemic intercurrent illness, including the following:

- Poorly controlled diabetes

- Active infection

- No history of significant neurological or mental disorder, including seizures or dementia

- No malignancy within the past 5 years, except carcinoma in situ of the cervix, or nonmelanomatous carcinoma of the skin

- No active cardiac disease uncontrolled by therapy

- No myocardial infarction within the past 12 months

- No interstitial lung disease or extended fibrosis of lung

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy for esophageal cancer

- No prior surgical procedure affecting absorption

- No concurrent flucytosine or other fluoropyrimidine-group anticancer drugs

- No concurrent systemic chemotherapy, investigational drug, or radiotherapy

Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
cisplatin

tegafur-gimeracil-oteracil potassium

Other:
cytology specimen collection procedure

Procedure:
endoscopic biopsy


Locations

Country Name City State
Korea, Republic of Yonsei Cancer Center at Yonsei University Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response rate No
Secondary Overall survival No
Secondary Progression-free survival No
Secondary Toxicity Yes
Secondary Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival No
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