- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00190554
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
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
-
-
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
No
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
Collaborators
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.
Helpful Links
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
September 13, 2005
First Posted (ESTIMATE)
September 19, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 22, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cisplatin
- Fluorouracil
Other Study ID Numbers
- JCOG9907
- C000000223
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Squamous Cell
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Emory UniversitySynta Pharmaceuticals Corp.TerminatedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage I Hypopharyngeal Squamous Cell Carcinoma | Stage I Laryngeal Squamous Cell Carcinoma | Stage I Oropharyngeal Squamous Cell Carcinoma | Stage II... and other conditionsUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage... and other conditionsCanada, United States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Caregiver | Salivary Gland Squamous Cell Carcinoma | Malignant Head and Neck Neoplasm | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
NRG OncologyNational Cancer Institute (NCI)RecruitingAdvanced Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of Unknown Primary | Advanced Hypopharyngeal Squamous Cell Carcinoma | Advanced Laryngeal Squamous Cell Carcinoma | Advanced Oropharyngeal Squamous Cell CarcinomaUnited States, Canada
-
City of Hope Medical CenterNational Cancer Institute (NCI); Genentech, Inc.RecruitingLocally Advanced Skin Squamous Cell Carcinoma | Unresectable Skin Squamous Cell Carcinoma | Resectable Skin Squamous Cell CarcinomaUnited States
-
Baptist Health South FloridaRegeneron PharmaceuticalsWithdrawnSquamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Advanced Squamous Cell CarcinomaUnited States
-
Hyunseok Kang, MDNeoImmuneTechRecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Resectable Oropharyngeal Squamous Cell CarcinomaUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteAstraZeneca; Brooklyn ImmunoTherapeutics, LLCActive, not recruitingSquamous Cell Carcinoma of the Head and Neck | Oropharynx Squamous Cell Carcinoma | Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | Metastatic Squamous Cell Carcinoma | Hypopharynx Squamous Cell Carcinoma | Paranasal Sinus Squamous Cell Carcinoma | Larynx Squamous Cell CarcinomaUnited States
Clinical Trials on Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2
-
Medical College of WisconsinUniversity of CincinnatiCompletedPancreatic AdenocarcinomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingPeritoneal Carcinomatosis | Stage IV Uterine Corpus Cancer AJCC v8 | Stage IVA Uterine Corpus Cancer AJCC v8 | Stage IVB Uterine Corpus Cancer AJCC v8 | Metastatic Malignant Solid Neoplasm | Malignant Uterine Neoplasm | Clinical Stage IV Gastric Cancer AJCC v8 | Metastatic Colorectal Carcinoma | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingPRETEXT I Hepatoblastoma | PRETEXT II Hepatoblastoma | PRETEXT III Hepatoblastoma | PRETEXT IV HepatoblastomaUnited States, Canada, Puerto Rico, Australia, Japan, Brazil