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

Not Applicable

• Conditions: Esophageal Cancer
• Interventions: Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy

• Registration Number: NCT00766480
• Lead Sponsor: University of Toyama

Brief 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.

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Status Verified: 2009-07
• Primary Completion: 2010-03
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regimen 1	radiation therapy	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	radiation therapy	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.
Regimen 1	cisplatin	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 1	fluorouracil	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	cisplatin	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.
Regimen 2	fluorouracil	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.

Primary Outcome Measures

Name	Time	Method
1-year progression-free survival
1-year local progression-free survival
3-year progression-free survival
3-year overall survival
Complete histological response

Trial Locations

Locations (20)

Aichi Cancer Center; 🇯🇵 Nagoya, Aichi, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa, Chiba, Japan

Kurume University School of Medicine; 🇯🇵 Kurume, Fukuoka, Japan

Gunma University Graduate School of Medicine; 🇯🇵 Maebashi-shi, Gunma, Japan

Hyogo College of Medicine; 🇯🇵 Nishinomiya, Hyogo, Japan

Iwate Medical University Hospital; 🇯🇵 Morioka, Iwate, Japan

Kawasaki Medical School; 🇯🇵 Kurashiki, Okayama, Japan

Graduate School of Medical Science at the University of Ryukyu; 🇯🇵 Nishiharacho, Okinawa, Japan

Kinki University School of Medicine; 🇯🇵 Osakasayama, Osaka, Japan

Osaka University Graduate School of Medicine; 🇯🇵 Suita, Osaka, Japan

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