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Elderly NSCLC/D vs DP (JCOG0207)

Primary Purpose

Non-small-cell Lung Cancer

Status
Terminated
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Weekly docetaxel alone
Weekly docetaxel + cisplatin combination
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small-cell Lung Cancer focused on measuring Elderly, advanced, non-small-cell lung cancer, cisplatin, docetaxel, weekly, combination, chemotherapy, randomized trial

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: histologically or cytologically proven non-small-cell lung cancer stage IV, or stage III disease ineligible for definitive radiotherapy 70 years or older ECOG PS 0-1 Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms No prior surgery within 4 weeks before enrollment No prior radiotherapy for primary tumor No prior radiotherapy for metastatic lesions within 2 weeks before enrollment Adequate organ function Signed informed consent Exclusion Criteria: Symptomatic brain metastasis Active another neoplasms Severe SVC syndrome Massive pericardial, pleural effusion, or ascites Bone metastasis emergent for palliative radiotherapy or surgery Uncontrollable systemic hypertension Heart failure, Unstable angina, Myocardial infarction within 6 months Uncontrollable diabetes Active infection Interstitial pneumonia/ Pulmonary fibrosis Hypersensitivity for polysorbate 80 Systemic administration of corticosteroids

Sites / Locations

  • Aichi Cancer Center Hospital
  • Aichi Cancer Center,Aichi Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Kyushu University Hospital
  • Gifu Municipal Hospital
  • Gunma Prefectural Cancer Center
  • National Nishigunma Hospital
  • National Hospital Organization, Dohoku National Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Hyogo Medical Center for Adults
  • Hyogo College of Medicine
  • Ibaraki Kenritsu Chuo Hospital & Cancer Center
  • Kanagawa Cancer Center
  • Yokohama Mucipical Citizen's Hospital
  • Kumamoto Regional Medical Center Hospital
  • Niigata Cancer Center Hospital
  • Osaka Prefectural Medical Center for Respiratory and Allergic Disease
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Osaka City General Hospital
  • Kinki University School of Medicine
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • National Hospital Organization Toneyama National Hospital
  • Saitama Cancer Center
  • Sizuoka Cancer Center
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • International Medical Center of Japan
  • Yamagata Prefectural Central Hospital

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Toxicity
Progression-free survival
Response rate
Symptom score

Full Information

First Posted
September 11, 2005
Last Updated
September 8, 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
NCT00190476
Brief Title
Elderly NSCLC/D vs DP (JCOG0207)
Official Title
Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (undefined)

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 evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Detailed Description
The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination. Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
Keywords
Elderly, advanced, non-small-cell lung cancer, cisplatin, docetaxel, weekly, combination, chemotherapy, randomized trial

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Weekly docetaxel alone
Intervention Type
Drug
Intervention Name(s)
Weekly docetaxel + cisplatin combination
Primary Outcome Measure Information:
Title
overall survival
Secondary Outcome Measure Information:
Title
Toxicity
Title
Progression-free survival
Title
Response rate
Title
Symptom score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically or cytologically proven non-small-cell lung cancer stage IV, or stage III disease ineligible for definitive radiotherapy 70 years or older ECOG PS 0-1 Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms No prior surgery within 4 weeks before enrollment No prior radiotherapy for primary tumor No prior radiotherapy for metastatic lesions within 2 weeks before enrollment Adequate organ function Signed informed consent Exclusion Criteria: Symptomatic brain metastasis Active another neoplasms Severe SVC syndrome Massive pericardial, pleural effusion, or ascites Bone metastasis emergent for palliative radiotherapy or surgery Uncontrollable systemic hypertension Heart failure, Unstable angina, Myocardial infarction within 6 months Uncontrollable diabetes Active infection Interstitial pneumonia/ Pulmonary fibrosis Hypersensitivity for polysorbate 80 Systemic administration of corticosteroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akira Yokoyama, MD, PhD
Organizational Affiliation
Department of Internal Medicine, Niigata Cancer Center 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
Aichi Cancer Center,Aichi Hospital
City
Okazaki,Kake-machi,Kuriyado,18
State/Province
Aichi
ZIP/Postal Code
444-0011
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
Kyushu University Hospital
City
Higashi-ku,Maidashi,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu,Kashima-cho,7-1
State/Province
Gifu
ZIP/Postal Code
500-8323
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota,Takabayashi-nishi-cho,617-1
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
National Nishigunma Hospital
City
Shibukawa,Kanai,2854
State/Province
Gunma
ZIP/Postal Code
377-8511
Country
Japan
Facility Name
National Hospital Organization, Dohoku National Hospital
City
Asahikawa,Hanasaki,7-4048
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo Medical Center for Adults
City
Akashi,Kitaouji-cho,13-70
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Hyogo College of Medicine
City
Nishinomiya,Mukogawa-cho,1-1
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Ibaraki Kenritsu Chuo Hospital & Cancer Center
City
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528
State/Province
Ibaraki
ZIP/Postal Code
309-1793
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
Yokohama Mucipical Citizen's Hospital
City
Yokohama,Hodogaya-ku,Okazawa-cho,56
State/Province
Kanagawa
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Kumamoto Regional Medical Center Hospital
City
Kumamoto,Honjo,5-16-10
State/Province
Kumamoto
ZIP/Postal Code
860-0811
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 Prefectural Medical Center for Respiratory and Allergic Disease
City
Habikino,Habikino,3-7-1
State/Province
Osaka
ZIP/Postal Code
583-8588
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
Osaka City General Hospital
City
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Kinki University School of Medicine
City
Osaka-Sayama,Ohno-higashi,377-2
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Sakai,Nagasone,1180
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
National Hospital Organization Toneyama National Hospital
City
Toyonaka,Toneyama,5-1-1
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi,Ina,Komuro,818
State/Province
Saitama
ZIP/Postal Code
362-0806
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
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
International Medical Center of Japan
City
Shinjuku-ku,Toyama,1-21-1
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata,Aoyagi,1800
State/Province
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25378648
Citation
Tsukada H, Yokoyama A, Goto K, Shinkai T, Harada M, Ando M, Shibata T, Ohe Y, Tamura T, Saijo N; Lung Cancer Study Group of the Japan Clinical Oncology Group (JCOG). Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207dagger. Jpn J Clin Oncol. 2015 Jan;45(1):88-95. doi: 10.1093/jjco/hyu176. Epub 2014 Nov 6.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
Related Info

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Elderly NSCLC/D vs DP (JCOG0207)

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