Study of Tissue Samples in Predicting How Well Chemotherapy and Radiation Therapy Will Kill Cancer Cells in Patients With Squamous Cell Carcinoma of the Esophagus

NCT00766480 | Unknown

• 2 other identifiers: CDR0000615602TOYAMAU-TRIEC0601
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 20

Brief Summary

RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying tissue samples in predicting how well chemotherapy and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the esophagus.

Conditions

Esophageal Cancer

Keywords

squamous cell carcinoma of the esophagus; stage IIA esophageal cancer; stage IIB esophageal cancer; stage IIIA esophageal cancer; stage IIIB esophageal cancer; stage IIIC esophageal cancer

Outcome Measures

Primary Outcomes (5)

• 1-year progression-free survival

• 1-year local progression-free survival

• 3-year progression-free survival

• 3-year overall survival

• Complete histological response

Study Arms (2)

Regimen 1

EXPERIMENTAL

Patients receive low-dose cisplatin IV on days 1 and 29 and low-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on days 1-4 and 29-32. Patients undergo salvage surgery if needed.

Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy

Regimen 2

EXPERIMENTAL

Patients receive high-dose cisplatin IV on days 1 and 29 and high-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1.

Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy

Interventions

cisplatin DRUG

Given IV

Regimen 1; Regimen 2

fluorouracil DRUG

Given IV

Regimen 1; Regimen 2

radiation therapy RADIATION

Patients undergo radiotherapy

Regimen 1; Regimen 2

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the thoracic esophagus * Stage IIA, IIB, or III (except T4) disease * Tumor diameter \< 8 cm * No tumor extension to the cervical esophagus or cardia of the stomach * No multiple and different histological types of cancer PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 4,000/mm³ * Absolute neutrophil count ≥ 2,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dL * AST and ALT ≤ 100 IU/L * Total serum bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.2 mg/dL * Creatinine clearance ≥ 60mL/min * SpO\_2 (room air) ≥ 95% * Not pregnant or nursing * No abnormal ECG findings requiring treatment * No interstitial pneumonitis or no pulmonary fibrosis * No severe complication (e.g., heart failure, renal failure, hepatic failure, or uncontrollable diabetes mellitus) * No collagen disease (e.g., PSS or dermatomyositis) * No mental disease * No active bacterial infection * No virus infection (i.e., HBV, HCV, PTHA, or HIV) PRIOR CONCURRENT THERAPY: * No prior surgery for esophageal cancer * No prior chemotherapy * No prior chest radiotherapy

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

Sponsors & Collaborators

• University of Toyama: lead

Study Sites (20)

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

National Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

RECRUITING

Kurume University School of Medicine

Kurume, Fukuoka, 830-0011, Japan

RECRUITING

Gunma University Graduate School of Medicine

Maebashi, Gunma, 371-8511, Japan

RECRUITING

Hiroshima City Asa Hospital

Hiroshima, Hiroshima, 731-0293, Japan

RECRUITING

Hyogo College of Medicine

Nishinomiya, Hyōgo, 663-8501, Japan

RECRUITING

Iwate Medical University Hospital

Morioka, Iwate, 020-8505, Japan

RECRUITING

Kagoshima University

Kagoshima, Kagoshima-ken, 890-8520, Japan

RECRUITING

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

RECRUITING

Niigata University Medical and Dental Hospital

Niigata, Niigata, 951-8510, Japan

RECRUITING

Niigata Cancer Center Hospital

Niigata, Niigata, 951-8566, Japan

RECRUITING

Kawasaki Medical School

Kurashiki, Okayama-ken, 701-01, Japan

RECRUITING

Graduate School of Medical Science at the University of Ryukyu

Nishiharacho, Okinawa, 903-0215, Japan

RECRUITING

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, Osaka, 537-8511, Japan

RECRUITING

Kinki University School of Medicine

Sayama, Osaka, 589-8511, Japan

RECRUITING

Osaka University Graduate School of Medicine

Suita, Osaka, 565-0871, Japan

RECRUITING

Mita Hospital at the International University of Health and Welfare

Tokyo, Tokyo, 108-8329, Japan

RECRUITING

Tokyo Women's Medical University

Tokyo, Tokyo, 162-8666, Japan

RECRUITING

Toyama University Hospital

Toyama, Toyama, 930-8555, Japan

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Yutaka Shimada, MD, PhD

  University of Toyama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Last Updated: August 26, 2013

Record last verified: 2009-07

Locations

JP (20)