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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00766480
First received: October 3, 2008
Last updated: August 23, 2013
Last verified: July 2009
  Purpose

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.


Condition Intervention
Esophageal Cancer
Drug: cisplatin
Drug: fluorouracil
Radiation: radiation therapy

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 1-year progression-free survival [ Designated as safety issue: No ]
  • 1-year local progression-free survival [ Designated as safety issue: No ]
  • 3-year progression-free survival [ Designated as safety issue: No ]
  • 3-year overall survival [ Designated as safety issue: No ]
  • Complete histological response [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: January 2007
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: cisplatin
Given IV
Drug: fluorouracil
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: cisplatin
Given IV
Drug: fluorouracil
Given IV
Radiation: radiation therapy
Patients undergo radiotherapy

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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766480

Locations
Japan
Aichi Cancer Center
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Kurume University School of Medicine
Kurume, Fukuoka, Japan, 830-0011
Gunma University Graduate School of Medicine
Maebashi-shi, Gunma, Japan, 371-8511
Hyogo College of Medicine
Nishinomiya, Hyogo, Japan, 663-8501
Iwate Medical University Hospital
Morioka, Iwate, Japan, 020-8505
Kawasaki Medical School
Kurashiki, Okayama, Japan, 701-01
Graduate School of Medical Science at the University of Ryukyu
Nishiharacho, Okinawa, Japan, 903-0215
Kinki University School of Medicine
Osakasayama, Osaka, Japan, 589-8511
Osaka University Graduate School of Medicine
Suita, Osaka, Japan, 565-0871
National Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Hiroshima City Asa Hospital
Hiroshima, Japan, 731-0293
Kagoshima University
Kagoshima, Japan, 890-8520
Kyoto University Hospital
Kyoto, Japan, 606-8507
Niigata University Medical and Dental Hospital
Niigata, Japan, 951-8510
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 537-8511
Mita Hospital at the International University of Health and Welfare
Tokyo, Japan, 108-8329
Tokyo Women's Medical University
Tokyo, Japan, 162-8666
Toyama University Hospital
Toyama, Japan, 930-8555
Sponsors and Collaborators
University of Toyama
Investigators
Principal Investigator: Yutaka Shimada, MD, PhD University of Toyama
  More Information

ClinicalTrials.gov Identifier: NCT00766480     History of Changes
Other Study ID Numbers: CDR0000615602  TOYAMAU-TRIEC0601 
Study First Received: October 3, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016