Back to resultsS-1, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIA, Stage III, or Stage IVA Esophageal Cancer That Can Be Removed by Surgery
Primary Purpose
Esophageal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cisplatin
tegafur-gimeracil-oteracil potassium
cytology specimen collection procedure
endoscopic biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer, stage IV esophageal cancer
Eligibility 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
Sites / Locations
- Yonsei Cancer Center at Yonsei University Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Response rate
Secondary Outcome Measures
Overall survival
Progression-free survival
Toxicity
Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00659113
Brief Title
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
Official Title
A Phase II Trial of a TS-1/Cisplatin Based Definitive Chemoradiotherapy for Resectable Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
tegafur-gimeracil-oteracil potassium
Intervention Type
Other
Intervention Name(s)
cytology specimen collection procedure
Intervention Type
Procedure
Intervention Name(s)
endoscopic biopsy
Primary Outcome Measure Information:
Title
Response rate
Secondary Outcome Measure Information:
Title
Overall survival
Title
Progression-free survival
Title
Toxicity
Title
Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, MD
Organizational Affiliation
Yonsei University
Official's Role
Study Chair
Facility Information:
Facility Name
Yonsei Cancer Center at Yonsei University Medical Center
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo-Hang Kim, MD
Phone
82-2-2228-8131
Email
kjhang@yuhs.ac
12. IPD Sharing Statement
Learn more about this trial
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
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