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

Primary Purpose

Esophageal Neoplasms, Carcinoma, Squamous Cell

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2
(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Neoplasms focused on measuring esophageal cancer, squamous cell carcinoma, esophagectomy, neoadjuvant chemotherapy, esophageal squamous cell carcinoma

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer Center Hospital
  • Chiba University, Graduate School of Medicine
  • Tokyo Dental College Ichikawa General Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Kurume University School of Medicine
  • Hiroshima City Asa Hospital
  • Iwate Medical University
  • Tokai University School of Medicine
  • Kanagawa Cancer Center
  • Kyoto University Hospital
  • Niigata University Medical and Dental Hospital
  • Niigata Cancer Center Hospital
  • Osaka National Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Sizuoka Cancer Center
  • Tochigi Cancer Center
  • Juntendo University School of Medicine
  • Tokyo Medical and Dental University Hospital
  • National Cancer Center Hospital
  • National Hospital Organization Tokyo Medical Center
  • Toranomon Hospital
  • Tokyo Women's Medical University
  • Keio University Hospital

Outcomes

Primary Outcome Measures

Disease free survival

Secondary Outcome Measures

Overall survival
Toxicity of chemotherapy
Operative morbidity

Full Information

First Posted
September 13, 2005
Last Updated
September 20, 2016
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00190554
Brief Title
A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
May 2000 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasms, Carcinoma, Squamous Cell
Keywords
esophageal cancer, squamous cell carcinoma, esophagectomy, neoadjuvant chemotherapy, esophageal squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2
Intervention Type
Drug
Intervention Name(s)
(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery
Primary Outcome Measure Information:
Title
Disease free survival
Time Frame
year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
year
Title
Toxicity of chemotherapy
Time Frame
year
Title
Operative morbidity
Time Frame
year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobutoshi Ando, M.D.
Organizational Affiliation
Tokyo Dental College Ichikawa General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya,Chikusa-ku,Kanokoden,1-1
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Chiba University, Graduate School of Medicine
City
Chiba,Chuo-ku,Inohana,1-8-1
State/Province
Chiba
ZIP/Postal Code
260-8670
Country
Japan
Facility Name
Tokyo Dental College Ichikawa General Hospital
City
Ichikawashi,Sugano,5-11-13
State/Province
Chiba
ZIP/Postal Code
2728513
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa,Kashiwanoha,6-5-1
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama,Horinouchi,13
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Kurume University School of Medicine
City
Kurume,Asahi-machi,67
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hiroshima City Asa Hospital
City
Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1
State/Province
Hiroshima
ZIP/Postal Code
731-0293
Country
Japan
Facility Name
Iwate Medical University
City
Morioka,Uchimaru,19-1
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Tokai University School of Medicine
City
Isehara,Shimokasuya,143
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama,Asahi-ku,Nakao,1-1-2
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto,Sakyo-ku,Syogoinkawara,54
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata,Asahimachi-dori,1-754
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata,Kawagishi-cho,2-15-3
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka National Hospital
City
Osaka,Chuo-ku,Hoenzaka,2-1-14
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka,Higashinari-ku,Nakamichi,1-3-3
State/Province
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Sizuoka Cancer Center
City
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya,Yohnan,4-9-13
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Juntendo University School of Medicine
City
Bunkyo-ku,Hongo,3-1-3
State/Province
Tokyo
ZIP/Postal Code
113-0033
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-ku,Yushima,1-5-45
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Meguro-ku,Higashigaoka,2-5-1
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku,Toranomon,2-2-2
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Shinjuku-ku,Kawada-cho,8-1
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku,Shinanomachi,35
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
21918956
Citation
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
Related Info

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

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