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

December 3, 2011 updated by: Yonsei University

A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer

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.

Study Overview

Status

Unknown

Conditions

Esophageal Cancer

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of, 120-752
    - Recruiting
    - Yonsei Cancer Center at Yonsei University Medical Center
    - Contact:
      
      Joo-Hang Kim, MD
      
      Phone Number: 82-2-2228-8131
      
      Email: kjhang@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate

Secondary Outcome Measures

Outcome Measure
Toxicity
Progression-free survival
Overall survival
Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Estimate)

December 6, 2011

Last Update Submitted That Met QC Criteria

December 3, 2011

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000593402
YONSEI-4-2007-0342

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.