A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma

September 20, 2016 updated by: Japan Clinical Oncology Group

A Randomized Controlled Trial of Chemotherapy With 5FU and Cisplatin Before and After Surgery for Stage II,III Squamous Cell Carcinoma of the Thoracic Esophagus:JCOG9907

To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The previous study JCOG9204 showed that postoperative adjuvant chemotherapy with cisplatin and fluorouracil has a detectable preventive effect on relapse in patients with esophageal squamous cell carcinoma compared with surgery alone.(J Clin Oncol 2003;21:4592-4596) Therefore the standard treatment for stage II and III esophageal cancer is adjuvant chemotherapy after surgery.

Study Type

Interventional

Enrollment

330

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- Aichi
  - Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
    - Aichi Cancer Center Hospital
- Chiba
  - Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan, 260-8670
    - Chiba University, Graduate School of Medicine
  - Ichikawashi,Sugano,5-11-13, Chiba, Japan, 2728513
    - Tokyo Dental College Ichikawa General Hospital
  - Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
    - National Cancer Center Hospital East
- Ehime
  - Matsuyama,Horinouchi,13, Ehime, Japan, 790-0007
    - National Hospital Organization Shikoku Cancer Center
- Fukuoka
  - Kurume,Asahi-machi,67, Fukuoka, Japan, 830-0011
    - Kurume University School of Medicine
- Hiroshima
  - Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1, Hiroshima, Japan, 731-0293
    - Hiroshima City Asa Hospital
- Iwate
  - Morioka,Uchimaru,19-1, Iwate, Japan, 020-8505
    - Iwate Medical University
- Kanagawa
  - Isehara,Shimokasuya,143, Kanagawa, Japan, 259-1193
    - Tokai University School of Medicine
  - Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan, 241-0815
    - Kanagawa Cancer Center
- Kyoto
  - Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan, 606-8507
    - Kyoto University Hospital
- Niigata
  - Niigata,Asahimachi-dori,1-754, Niigata, Japan, 951-8520
    - Niigata University Medical and Dental Hospital
  - Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
    - Niigata Cancer Center Hospital
- Osaka
  - Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, Japan, 540-0006
    - Osaka National Hospital
  - Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, Japan, 537-8511
    - Osaka Medical Center for Cancer and Cardiovascular Diseases
- Shizuoka
  - Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, Japan, 411-8777
    - Sizuoka Cancer Center
- Tochigi
  - Utsunomiya,Yohnan,4-9-13, Tochigi, Japan, 320-0834
    - Tochigi Cancer Center
- Tokyo
  - Bunkyo-ku,Hongo,3-1-3, Tokyo, Japan, 113-0033
    - Juntendo University School of Medicine
  - Bunkyo-ku,Yushima,1-5-45, Tokyo, Japan, 113-8519
    - Tokyo Medical and Dental University Hospital
  - Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
  - Meguro-ku,Higashigaoka,2-5-1, Tokyo, Japan, 152-8902
    - National Hospital Organization Tokyo Medical Center
  - Minato-ku,Toranomon,2-2-2, Tokyo, Japan, 105-8470
    - Toranomon Hospital
  - Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan, 162-8666
    - Tokyo Women's Medical University
  - Shinjuku-ku,Shinanomachi,35, Tokyo, Japan, 160-8582
    - Keio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

histologically proven squamous cell carcinoma of the thoracic esophagus
pathologic stages IIa, IIb, III except T4
an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
no previous history of chemotherapy nor radiotherapy
an essentially normal clinical laboratory profile (white blood cell count or WBC, >=4,000 /mm3; hemoglobin or Hb, >=10g/dl; platelet count or Plt, >=100,000 /mm3; total serum bilirubin<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, <=1.2 mg/dl; creatinine clearance or CCr, >=60 ml/minute; and arterial oxygen tension or PaO2, >=65 torr
oral or written informed consent obtained before randomization

Exclusion Criteria:

severe heart diseases
uncontrollable hyper tension or diabetes mellitus
severe pulmonary dysfunction
HBs positive
active bacterial infection
synchronous or metachronous (within 5 years) malignancy
pregnant female
psychiatric medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease free survival Time Frame: year	year

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival Time Frame: year	year
Toxicity of chemotherapy Time Frame: year	year
Operative morbidity Time Frame: year	year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

Study Chair: Nobutoshi Ando, M.D., Tokyo Dental College Ichikawa General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Hirao M, Ando N, Tsujinaka T, Udagawa H, Yano M, Yamana H, Nagai K, Mizusawa J, Nakamura K; Japan Esophageal Oncology Group/Japan Clinical Oncology Group. Influence of preoperative chemotherapy for advanced thoracic oesophageal squamous cell carcinoma on perioperative complications. Br J Surg. 2011 Dec;98(12):1735-41. doi: 10.1002/bjs.7683. Epub 2011 Sep 14.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Primary Completion (ACTUAL)

May 1, 2004

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria