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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

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

cisplatin

fluorouracil

radiation therapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

20 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Aichi Cancer CenterRecruiting
National Cancer Center Hospital EastRecruiting
Kurume University School of MedicineRecruiting
Gunma University Graduate School of MedicineRecruiting
Hyogo College of MedicineRecruiting
Iwate Medical University HospitalRecruiting
Kawasaki Medical SchoolRecruiting
Graduate School of Medical Science at the University of RyukyuRecruiting
Kinki University School of MedicineRecruiting
Osaka University Graduate School of MedicineRecruiting
National Kyushu Cancer CenterRecruiting
Hiroshima City Asa HospitalRecruiting
Kagoshima UniversityRecruiting
Kyoto University HospitalRecruiting
Niigata University Medical and Dental HospitalRecruiting
Niigata Cancer Center HospitalRecruiting
Osaka Medical Center for Cancer and Cardiovascular DiseasesRecruiting
Mita Hospital at the International University of Health and WelfareRecruiting
Tokyo Women's Medical UniversityRecruiting
Toyama University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Regimen 1

Regimen 2

Arm Description

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.

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.

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00766480

First Posted

October 3, 2008

Last Updated

August 23, 2013

Sponsor

University of Toyama

1. Study Identification

Unique Protocol Identification Number

NCT00766480

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

March 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Toyama

4. Oversight

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

None (Open Label)

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Regimen 1

Arm Type

Experimental

Arm Description

Arm Title

Regimen 2

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Intervention Description

Given IV

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Intervention Description

Patients undergo radiotherapy

Primary Outcome Measure Information:

Title

1-year progression-free survival

Title

1-year local progression-free survival

Title

3-year progression-free survival

Title

3-year overall survival

Title

Complete histological response

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yutaka Shimada, MD, PhD

Organizational Affiliation

University of Toyama

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aichi Cancer Center

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

464-8681

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shunzo Hatooka

Phone

81-52-762-6111

Facility Name

National Cancer Center Hospital East

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Keiko Minashi

Phone

81-4-7133-1111

Facility Name

Kurume University School of Medicine

City

Kurume

State/Province

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Toshiaki Tanaka

Phone

81-942-35-3311

Facility Name

Gunma University Graduate School of Medicine

City

Maebashi-shi

State/Province

Gunma

ZIP/Postal Code

371-8511

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hiroyuki Kuwano, MD, PhD

Phone

81-27-220-8224

hkuwano@med.gunma-u.ac.jp

Facility Name

Hyogo College of Medicine

City

Nishinomiya

State/Province

Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Koushi Oh

Phone

81-798-45-6582

Facility Name

Iwate Medical University Hospital

City

Morioka

State/Province

Iwate

ZIP/Postal Code

020-8505

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenichiro Ikeda

Phone

81-19-651-5111

Facility Name

Kawasaki Medical School

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

701-01

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Toshihiro Hirai

Phone

81-86-462-1199

Facility Name

Graduate School of Medical Science at the University of Ryukyu

City

Nishiharacho

State/Province

Okinawa

ZIP/Postal Code

903-0215

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tadashi Nishimaki

Phone

81-98-895-3331

Facility Name

Kinki University School of Medicine

City

Osakasayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Takushi Yasuda

Phone

81-72-366-0221

Facility Name

Osaka University Graduate School of Medicine

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Masaichi Ohira

Phone

81-6-6645-3837

Facility Name

National Kyushu Cancer Center

City

Fukuoka

ZIP/Postal Code

811-1395

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yasushi Toh, MD, PhD

Phone

81-92-541-3231

Facility Name

Hiroshima City Asa Hospital

City

Hiroshima

ZIP/Postal Code

731-0293

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hidenori Mukaida

Phone

81-82-815-5211

Facility Name

Kagoshima University

City

Kagoshima

ZIP/Postal Code

890-8520

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shoji Natsugoe

Phone

81-99-275-5361

Facility Name

Kyoto University Hospital

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michihide Mitsumori

Phone

81-75-751-3417

Facility Name

Niigata University Medical and Dental Hospital

City

Niigata

ZIP/Postal Code

951-8510

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tatsuo Kanda, MD

Phone

81-25-227-2228

Facility Name

Niigata Cancer Center Hospital

City

Niigata

ZIP/Postal Code

951-8566

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hiroshi Yabusaki

Phone

81-25-266-5111

Facility Name

Osaka Medical Center for Cancer and Cardiovascular Diseases

City

Osaka

ZIP/Postal Code

537-8511

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ryu Ishihara

Phone

81-6-6972-1181

Facility Name

Mita Hospital at the International University of Health and Welfare

City

Tokyo

ZIP/Postal Code

108-8329

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ken-ichi Mafune, MD

Phone

81-3-3451-8121

mafune@iuhw.ac.jp

Facility Name

Tokyo Women's Medical University

City

Tokyo

ZIP/Postal Code

162-8666

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tsutomu Nakamura

Phone

81-3-3353-8111

Facility Name

Toyama University Hospital

City

Toyama

ZIP/Postal Code

930-8555

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yutaka Shimada, MD, PhD

Phone

81-76-434-7331

12. IPD Sharing Statement

Learn more about this trial

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

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