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

Sponsor

University of Toyama (Other)

Overall Status

Unknown status

CT.gov ID

NCT00766480

Collaborator

(none)

160

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Masking:

None (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

Study Start Date :

Jan 1, 2007

Anticipated Primary Completion Date :

Mar 1, 2010

Arms and Interventions

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: 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

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: 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

Outcome Measures

Primary Outcome Measures

1-year progression-free survival []
1-year local progression-free survival []
3-year progression-free survival []
3-year overall survival []
Complete histological response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Aichi Cancer Center	Nagoya	Aichi	Japan	464-8681
2	National Cancer Center Hospital East	Kashiwa	Chiba	Japan	277-8577
3	Kurume University School of Medicine	Kurume	Fukuoka	Japan	830-0011
4	Gunma University Graduate School of Medicine	Maebashi-shi	Gunma	Japan	371-8511
5	Hyogo College of Medicine	Nishinomiya	Hyogo	Japan	663-8501
6	Iwate Medical University Hospital	Morioka	Iwate	Japan	020-8505
7	Kawasaki Medical School	Kurashiki	Okayama	Japan	701-01
8	Graduate School of Medical Science at the University of Ryukyu	Nishiharacho	Okinawa	Japan	903-0215
9	Kinki University School of Medicine	Osakasayama	Osaka	Japan	589-8511
10	Osaka University Graduate School of Medicine	Suita	Osaka	Japan	565-0871
11	National Kyushu Cancer Center	Fukuoka		Japan	811-1395
12	Hiroshima City Asa Hospital	Hiroshima		Japan	731-0293
13	Kagoshima University	Kagoshima		Japan	890-8520
14	Kyoto University Hospital	Kyoto		Japan	606-8507
15	Niigata University Medical and Dental Hospital	Niigata		Japan	951-8510
16	Niigata Cancer Center Hospital	Niigata		Japan	951-8566
17	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka		Japan	537-8511
18	Mita Hospital at the International University of Health and Welfare	Tokyo		Japan	108-8329
19	Tokyo Women's Medical University	Tokyo		Japan	162-8666
20	Toyama University Hospital	Toyama		Japan	930-8555