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 because the information has not been verified recently.
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
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 Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Shunzo Hatooka    81-52-762-6111      
National Cancer Center Hospital East Recruiting
Kashiwa, Chiba, Japan, 277-8577
Contact: Keiko Minashi    81-4-7133-1111      
Kurume University School of Medicine Recruiting
Kurume, Fukuoka, Japan, 830-0011
Contact: Toshiaki Tanaka    81-942-35-3311      
Gunma University Graduate School of Medicine Recruiting
Maebashi-shi, Gunma, Japan, 371-8511
Contact: Hiroyuki Kuwano, MD, PhD    81-27-220-8224    hkuwano@med.gunma-u.ac.jp   
Hyogo College of Medicine Recruiting
Nishinomiya, Hyogo, Japan, 663-8501
Contact: Koushi Oh    81-798-45-6582      
Iwate Medical University Hospital Recruiting
Morioka, Iwate, Japan, 020-8505
Contact: Kenichiro Ikeda    81-19-651-5111      
Kawasaki Medical School Recruiting
Kurashiki, Okayama, Japan, 701-01
Contact: Toshihiro Hirai    81-86-462-1199      
Graduate School of Medical Science at the University of Ryukyu Recruiting
Nishiharacho, Okinawa, Japan, 903-0215
Contact: Tadashi Nishimaki    81-98-895-3331      
Kinki University School of Medicine Recruiting
Osakasayama, Osaka, Japan, 589-8511
Contact: Takushi Yasuda    81-72-366-0221      
Osaka University Graduate School of Medicine Recruiting
Suita, Osaka, Japan, 565-0871
Contact: Masaichi Ohira    81-6-6645-3837      
National Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Contact: Yasushi Toh, MD, PhD    81-92-541-3231      
Hiroshima City Asa Hospital Recruiting
Hiroshima, Japan, 731-0293
Contact: Hidenori Mukaida    81-82-815-5211      
Kagoshima University Recruiting
Kagoshima, Japan, 890-8520
Contact: Shoji Natsugoe    81-99-275-5361      
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Michihide Mitsumori    81-75-751-3417      
Niigata University Medical and Dental Hospital Recruiting
Niigata, Japan, 951-8510
Contact: Tatsuo Kanda, MD    81-25-227-2228      
Niigata Cancer Center Hospital Recruiting
Niigata, Japan, 951-8566
Contact: Hiroshi Yabusaki    81-25-266-5111      
Osaka Medical Center for Cancer and Cardiovascular Diseases Recruiting
Osaka, Japan, 537-8511
Contact: Ryu Ishihara    81-6-6972-1181      
Mita Hospital at the International University of Health and Welfare Recruiting
Tokyo, Japan, 108-8329
Contact: Ken-ichi Mafune, MD    81-3-3451-8121    mafune@iuhw.ac.jp   
Tokyo Women's Medical University Recruiting
Tokyo, Japan, 162-8666
Contact: Tsutomu Nakamura    81-3-3353-8111      
Toyama University Hospital Recruiting
Toyama, Japan, 930-8555
Contact: Yutaka Shimada, MD, PhD    81-76-434-7331      
Sponsors and Collaborators
Toyama University Hospital
Investigators
Principal Investigator: Yutaka Shimada, MD, PhD Toyama University Hospital
  More Information

Additional Information:
No publications provided

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:
Esophageal Neoplasms
Carcinoma
Carcinoma, Squamous Cell
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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 10, 2014