Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
NCT ID: NCT00132665
Last Updated: 2012-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2003-07-31
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Procedure/Surgery: A: Radiotherapy alone
A: Radiotherapy alone
Procedure/Surgery: A: Radiotherapy alone
2
Drug: B: CBDCA and Radiotherapy
B: CBDCA and Radiotherapy
Drug: B: CBDCA and Radiotherapy
Interventions
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A: Radiotherapy alone
Procedure/Surgery: A: Radiotherapy alone
B: CBDCA and Radiotherapy
Drug: B: CBDCA and Radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
71 Years
ALL
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Japan Clinical Oncology Group
OTHER
Responsible Party
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Principal Investigators
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Masaaki Kawahawa, MD
Role: STUDY_CHAIR
Kinki-Chuo Chest Medical Center
Locations
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Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Aichi Cancer Center,Aichi Hospital
Okazaki, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
Natsuyama, Ehime, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Gifu Municipal Hospital
Gifu, Gifu, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, Japan
National Nishigunma Hospital
Shibukawa, Gunma, Japan
National Hospital Organization, Dohoku National Hospital
Asahikawa, Hokkaido, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Hyogo Medical Center for Adults
Akashi, Hyōgo, Japan
Kobe City General Hospital
Kobe, Hyōgo, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun, Ibaraki, Japan
Yokohama Mucipical Citizen's Hospital
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kumamoto Regional Medical Center Hospital
Kumamoto, Kumamoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino, Osaka, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
Osaka City General Hospital
Osaka, Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka, Japan
Graduate School of Medicine, Osaka City University
Osaka, Osaka, Japan
Osaka General Medical Center
Osaka, Osaka, Japan
Kinki University School of Medicine
Ōsaka-sayama, Osaka, Japan
Kinki-Chuo Chest Medical Center
Sakai, Osaka, Japan
National Hospital Organization Toneyama National Hospital
Toyonaka, Osaka, Japan
Saitama Cancer Center
Kita-adachi, Saitama, Japan
Sizuoka Cancer Center
Sunto-gun, Shizuoka, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Cancer Institute Hospital
Koto-ku, Tokyo, Japan
Toranomon Hospital
Minato-ku, Tokyo, Japan
International Medical Center of Japan
Shinjuku-ku, Tokyo, Japan
Yamagata Prefectural Central Hospital
Yamagata, Yamagata, Japan
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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C000000059
Identifier Type: REGISTRY
Identifier Source: secondary_id
JCOG0301
Identifier Type: -
Identifier Source: org_study_id