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

August 23, 2013 updated by: University of Toyama

An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 811-1395
        • Recruiting
        • National Kyushu Cancer Center
        • Contact:
          • Yasushi Toh, MD, PhD
          • Phone Number: 81-92-541-3231
      • Hiroshima, Japan, 731-0293
        • Recruiting
        • Hiroshima City Asa Hospital
        • Contact:
          • Hidenori Mukaida
          • Phone Number: 81-82-815-5211
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • Kagoshima University
        • Contact:
          • Shoji Natsugoe
          • Phone Number: 81-99-275-5361
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital
        • Contact:
          • Michihide Mitsumori
          • Phone Number: 81-75-751-3417
      • Niigata, Japan, 951-8566
        • Recruiting
        • Niigata Cancer Center Hospital
        • Contact:
          • Hiroshi Yabusaki
          • Phone Number: 81-25-266-5111
      • Niigata, Japan, 951-8510
        • Recruiting
        • Niigata University Medical And Dental Hospital
        • Contact:
          • Tatsuo Kanda, MD
          • Phone Number: 81-25-227-2228
      • Osaka, Japan, 537-8511
        • Recruiting
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
        • Contact:
          • Ryu Ishihara
          • Phone Number: 81-6-6972-1181
      • Tokyo, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University
        • Contact:
          • Tsutomu Nakamura
          • Phone Number: 81-3-3353-8111
      • Tokyo, Japan, 108-8329
        • Recruiting
        • Mita Hospital at the International University of Health and Welfare
        • Contact:
      • Toyama, Japan, 930-8555
        • Recruiting
        • Toyama University Hospital
        • Contact:
          • Yutaka Shimada, MD, PhD
          • Phone Number: 81-76-434-7331
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Recruiting
        • Aichi Cancer Center
        • Contact:
          • Shunzo Hatooka
          • Phone Number: 81-52-762-6111
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
          • Keiko Minashi
          • Phone Number: 81-4-7133-1111
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University School of Medicine
        • Contact:
          • Toshiaki Tanaka
          • Phone Number: 81-942-35-3311
    • Gunma
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Recruiting
        • Gunma University Graduate School of Medicine
        • Contact:
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Recruiting
        • Hyogo College of Medicine
        • Contact:
          • Koushi Oh
          • Phone Number: 81-798-45-6582
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Recruiting
        • Iwate Medical University Hospital
        • Contact:
          • Kenichiro Ikeda
          • Phone Number: 81-19-651-5111
    • Okayama
      • Kurashiki, Okayama, Japan, 701-01
        • Recruiting
        • Kawasaki Medical School
        • Contact:
          • Toshihiro Hirai
          • Phone Number: 81-86-462-1199
    • Okinawa
      • Nishiharacho, Okinawa, Japan, 903-0215
        • Recruiting
        • Graduate School of Medical Science at the University of Ryukyu
        • Contact:
          • Tadashi Nishimaki
          • Phone Number: 81-98-895-3331
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Recruiting
        • Kinki University School of Medicine
        • Contact:
          • Takushi Yasuda
          • Phone Number: 81-72-366-0221
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • Osaka University Graduate School of Medicine
        • Contact:
          • Masaichi Ohira
          • Phone Number: 81-6-6645-3837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: fluorouracil
Given IV
Drug: cisplatin
Given IV
Radiation: radiation therapy
Patients undergo radiotherapy
Experimental: 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.
Drug: fluorouracil
Given IV
Drug: cisplatin
Given IV
Radiation: radiation therapy
Patients undergo radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1-year progression-free survival
1-year local progression-free survival
3-year progression-free survival
3-year overall survival
Complete histological response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toyama

Investigators

  • Principal Investigator: Yutaka Shimada, MD, PhD, University of Toyama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (Estimate)

October 6, 2008

Study Record Updates

Last Update Posted (Estimate)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 23, 2013

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000615602
  • TOYAMAU-TRIEC0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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