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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00766480
• Other study ID #: CDR0000615602
• Secondary ID: TOYAMAU-TRIEC060
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2008
• Last updated: August 23, 2013
• Start date: January 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• cisplatin
Given IV
• fluorouracil
Given IV

Radiation:
• radiation therapy
Patients undergo radiotherapy

Locations

Country	Name	City	State
Japan	National Kyushu Cancer Center	Fukuoka
Japan	Hiroshima City Asa Hospital	Hiroshima
Japan	Kagoshima University	Kagoshima
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Kawasaki Medical School	Kurashiki	Okayama
Japan	Kurume University School of Medicine	Kurume	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	Gunma University Graduate School of Medicine	Maebashi-shi	Gunma
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Aichi Cancer Center	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Graduate School of Medical Science at the University of Ryukyu	Nishiharacho	Okinawa
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka
Japan	Kinki University School of Medicine	Osakasayama	Osaka
Japan	Osaka University Graduate School of Medicine	Suita	Osaka
Japan	Mita Hospital at the International University of Health and Welfare	Tokyo
Japan	Tokyo Women's Medical University	Tokyo
Japan	Toyama University Hospital	Toyama

Sponsors (1)

Lead Sponsor	Collaborator
University of Toyama

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year progression-free survival			No
Primary	1-year local progression-free survival			No
Primary	3-year progression-free survival			No
Primary	3-year overall survival			No
Primary	Complete histological response			No