S-1, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIA, Stage III, or Stage IVA Esophageal Cancer That Can Be Removed by Surgery

NCT ID: NCT00659113

Last Updated: 2011-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31

Brief 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.

Detailed 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.

Conditions

Esophageal Cancer

Keywords

stage IIA esophageal cancer; stage IIB esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer; stage IV esophageal cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

tegafur-gimeracil-oteracil potassium

Intervention Type: DRUG

cytology specimen collection procedure

Intervention Type: OTHER

endoscopic biopsy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Principal Investigators

Joo-Hang Kim, MD

Role: STUDY_CHAIR

Yonsei University

Locations

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Joo-Hang Kim, MD

Role: primary

Other Identifiers

YONSEI-4-2007-0342

Identifier Type: -

Identifier Source: secondary_id

CDR0000593402

Identifier Type: -

Identifier Source: org_study_id