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

NCT00659113 | Unknown Phase 2

• 2 other identifiers: CDR0000593402YONSEI-4-2007-0342
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Response rate

Secondary Outcomes (4)

• Overall survival

• Progression-free survival

• Toxicity

• Initial squamous cell carcinoma antigen and C-reactive protein correlation with response and survival

Interventions

cisplatin DRUG

tegafur-gimeracil-oteracil potassium DRUG

cytology specimen collection procedure OTHER

endoscopic biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Cisplatin; Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Joo-Hang Kim, MD

  Yonsei University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 16, 2008
• Study Start: March 1, 2008
• Last Updated: December 6, 2011

Record last verified: 2008-12

Locations

KR (1)