- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00132665
Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
December 6, 2012 updated by: Japan Clinical Oncology Group
Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients With Locally Advanced Non-small Cell Lung Cancer (JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.
Study Type
Interventional
Enrollment (Actual)
200
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
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Gifu, Japan, 500-8323
- Gifu Municipal Hospital
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Kumamoto, Japan, 860-0811
- Kumamoto Regional Medical Center Hospital
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Osaka, Japan, 558-8558
- Osaka General Medical Center
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Osaka, Japan, 534-0021
- Osaka City General Hospital
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Osaka, Japan, 537-8511
- Osaka Medical Center for Cancer and Cardiovascular Diseases
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Osaka, Japan, 545-0051
- Graduate School of Medicine, Osaka City University
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Yamagata, Japan, 990-2292
- Yamagata Prefectural Central Hospital
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Aichi
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Nagoya, Aichi, Japan, 464-8681
- Aichi Cancer Center Hospital
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Okazaki, Aichi, Japan, 444-0011
- Aichi Cancer Center,Aichi Hospital
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Ehime
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Natsuyama, Ehime, Japan, 790-0007
- National Hospital Organization Shikoku Cancer Center
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Gunma
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Ota, Gunma, Japan, 373-8550
- Gunma Prefectural Cancer Center
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Shibukawa, Gunma, Japan, 377-8511
- National Nishigunma Hospital
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Hokkaido
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Asahikawa, Hokkaido, Japan, 070-8644
- National Hospital Organization, Dohoku National Hospital
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Sapporo, Hokkaido, Japan, 003-0804
- National Hospital Organization Hokkaido Cancer Center
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Hyogo
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Akashi, Hyogo, Japan, 673-8558
- Hyogo Medical Center for Adults
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Kobe, Hyogo, Japan, 650-0046
- Kobe City General Hospital
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Nishinomiya, Hyogo, Japan, 663-8501
- Hyogo College of Medicine
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Ibaraki
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Nishi-ibarakigun, Ibaraki, Japan, 309-1793
- Ibaraki Kenritsu Chuo Hospital & Cancer Center
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-0815
- Kanagawa cancer center
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Yokohama, Kanagawa, Japan, 240-8555
- Yokohama Mucipical Citizen's Hospital
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
- Tohoku University Hospital
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Osaka
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Habikino, Osaka, Japan, 583-8588
- Osaka Prefectural Medical Center for Respiratory and Allergic Disease
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Izumisano, Osaka, Japan, 598-0048
- Rinku General Medical Center
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Osaka-Sayama, Osaka, Japan, 589-8511
- Kinki University School of Medicine
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Sakai, Osaka, Japan, 591-8555
- Kinki-Chuo Chest Medical Center
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Toyonaka, Osaka, Japan, 560-8552
- National Hospital Organization Toneyama National Hospital
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Saitama
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Kita-adachi, Saitama, Japan, 362-0806
- Saitama Cancer Center
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Shizuoka
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Sunto-gun, Shizuoka, Japan, 411-8777
- Sizuoka Cancer Center
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Tochigi
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Utsunomiya, Tochigi, Japan, 320-0834
- Tochigi Cancer Center
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Koto-ku, Tokyo, Japan, 135-8550
- Cancer Institute Hospital
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Minato-ku, Tokyo, Japan, 105-8470
- Toranomon Hospital
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Shinjuku-ku, Tokyo, Japan, 162-8655
- International Medical Center of Japan
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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
71 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically and/or cytologically proven NSCLC
- Unresectable disease
- Stage IIIA except T3N1M0 and IIIB which does not have disease extended to any contralateral hilar nodes, atelectasis of the entire lung or malignant pleural effusions
- A required radiation field of less than one half of one lung
- Measurable disease
- No previous chemotherapy or radiotherapy
- Age >= 71
- Unable to receive cisplatin-based combination chemotherapy
- ECOG performance status (PS) of 0-2
- Adequate bone marrow, lung, hepatic, and renal function
- Written informed consent
Exclusion Criteria:
- Active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, or severe other comorbidity
- Synchronous cancer or metachronous (within 5 years) malignancy
- Interstitial pneumonia or active lung fibrosis on chest X-ray
- Severe chronic obstructive pulmonary disease, chronic bronchitis, or bronchial asthma
- Pleural or pericardial effusion
- A history of severe hypersensitivity
- Mental disorder
- Judging of inappropriate condition for this study by physician
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Procedure/Surgery: A: Radiotherapy alone
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Procedure/Surgery: A: Radiotherapy alone
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Experimental: 2
Drug: B: CBDCA and Radiotherapy
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Drug: B: CBDCA and Radiotherapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: During the study conduct
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During the study conduct
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: During the study conduct
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During the study conduct
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Progression-free survival
Time Frame: During the study conduct
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During the study conduct
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Response rate
Time Frame: During the study conduct
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During the study conduct
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Pattern of progression/relapse
Time Frame: During the study conduct
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During the study conduct
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Masaaki Kawahawa, MD, Kinki-Chuo Chest Medical Center
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
- Atagi S, Mizusawa J, Ishikura S, Takahashi T, Okamoto H, Tanaka H, Goto K, Nakagawa K, Harada M, Takeda Y, Nogami N, Fujita Y, Kasai T, Kishi K, Sawa T, Takeda K, Tomii K, Satouchi M, Seto T, Ohe Y. Chemoradiotherapy in Elderly Patients With Non-Small-Cell Lung Cancer: Long-Term Follow-Up of a Randomized Trial (JCOG0301). Clin Lung Cancer. 2018 Sep;19(5):e619-e627. doi: 10.1016/j.cllc.2018.04.018. Epub 2018 May 5.
- Atagi S, Kawahara M, Yokoyama A, Okamoto H, Yamamoto N, Ohe Y, Sawa T, Ishikura S, Shibata T, Fukuda H, Saijo N, Tamura T; Japan Clinical Oncology Group Lung Cancer Study Group. Thoracic radiotherapy with or without daily low-dose carboplatin in elderly patients with non-small-cell lung cancer: a randomised, controlled, phase 3 trial by the Japan Clinical Oncology Group (JCOG0301). Lancet Oncol. 2012 Jul;13(7):671-8. doi: 10.1016/S1470-2045(12)70139-0. Epub 2012 May 22.
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
July 1, 2003
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
August 18, 2005
First Submitted That Met QC Criteria
August 18, 2005
First Posted (Estimate)
August 22, 2005
Study Record Updates
Last Update Posted (Estimate)
December 7, 2012
Last Update Submitted That Met QC Criteria
December 6, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JCOG0301
- C000000059 (Registry Identifier: UMIN-CTR)
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.
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