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

Esophageal Cancer Clinical Trial

Official title:

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

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
• 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

• Esophageal Cancer
• Esophageal Neoplasms

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