A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma
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
2 other identifiers
interventional
330
1 country
24
Brief Summary
To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2000
Longer than P75 for phase_3
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedSeptember 22, 2016
September 1, 2016
4 years
September 13, 2005
September 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival
year
Secondary Outcomes (3)
Overall survival
year
Toxicity of chemotherapy
year
Operative morbidity
year
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681, Japan
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, 260-8670, Japan
Tokyo Dental College Ichikawa General Hospital
Ichikawashi,Sugano,5-11-13, Chiba, 2728513, Japan
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007, Japan
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, 830-0011, Japan
Hiroshima City Asa Hospital
Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1, Hiroshima, 731-0293, Japan
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, 020-8505, Japan
Tokai University School of Medicine
Isehara,Shimokasuya,143, Kanagawa, 259-1193, Japan
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815, Japan
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, 606-8507, Japan
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, 951-8520, Japan
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566, Japan
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, 540-0006, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511, Japan
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777, Japan
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834, Japan
Juntendo University School of Medicine
Bunkyo-ku,Hongo,3-1-3, Tokyo, 113-0033, Japan
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519, Japan
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045, Japan
National Hospital Organization Tokyo Medical Center
Meguro-ku,Higashigaoka,2-5-1, Tokyo, 152-8902, Japan
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, 105-8470, Japan
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, 162-8666, Japan
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582, Japan
Related Publications (1)
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.
PMID: 21918956DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nobutoshi Ando, M.D.
Tokyo Dental College Ichikawa General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
May 1, 2000
Primary Completion
May 1, 2004
Study Completion
May 1, 2009
Last Updated
September 22, 2016
Record last verified: 2016-09