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

Last updated: August 23, 2013
Sponsor: University of Toyama
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Esophageal Disorders

Lung Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT00766480
CDR0000615602
TOYAMAU-TRIEC0601
  • Ages 20-74
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 160
Study Start date:
January 01, 2007
Estimated Completion Date:

Study Description

OBJECTIVES:

  • To search for chemoradiosensitivity-related genes using a pre-treatment biopsy sample in patients with esophageal squamous cell carcinoma treated with cisplatin, fluorouracil, and concurrent radiotherapy.

  • To establish an algorithm for prediction of chemoradiosensitivity in these patients.

OUTLINE: Patients receive 1 of the following treatment regimens:

  • Regimen 1: 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.

  • Regimen 2: 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.

Pre-operative biopsy samples are analyzed by DNA microarray chip to establish an algorithm for prediction of chemoradiosensitivity.

After completion of study therapy, patients are followed at 12 months.

Connect with a study center

  • Aichi Cancer Center

    Nagoya, Aichi 464-8681
    Japan

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • Kurume University School of Medicine

    Kurume, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Gunma University Graduate School of Medicine

    Maebashi-shi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Hyogo College of Medicine

    Nishinomiya, Hyogo 663-8501
    Japan

    Active - Recruiting

  • Iwate Medical University Hospital

    Morioka, Iwate 020-8505
    Japan

    Active - Recruiting

  • Kawasaki Medical School

    Kurashiki, Okayama 701-01
    Japan

    Active - Recruiting

  • Graduate School of Medical Science at the University of Ryukyu

    Nishiharacho, Okinawa 903-0215
    Japan

    Active - Recruiting

  • Kinki University School of Medicine

    Osakasayama, Osaka 589-8511
    Japan

    Active - Recruiting

  • Osaka University Graduate School of Medicine

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • National Kyushu Cancer Center

    Fukuoka, 811-1395
    Japan

    Active - Recruiting

  • Hiroshima City Asa Hospital

    Hiroshima, 731-0293
    Japan

    Active - Recruiting

  • Kagoshima University

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • Kyoto University Hospital

    Kyoto, 606-8507
    Japan

    Active - Recruiting

  • Niigata Cancer Center Hospital

    Niigata, 951-8566
    Japan

    Active - Recruiting

  • Niigata University Medical and Dental Hospital

    Niigata, 951-8510
    Japan

    Active - Recruiting

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, 537-8511
    Japan

    Active - Recruiting

  • Mita Hospital at the International University of Health and Welfare

    Tokyo, 108-8329
    Japan

    Active - Recruiting

  • Tokyo Women's Medical University

    Tokyo, 162-8666
    Japan

    Active - Recruiting

  • Toyama University Hospital

    Toyama, 930-8555
    Japan

    Active - Recruiting

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