Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
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)
2 other identifiers
interventional
200
1 country
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2003
Longer than P75 for phase_3
37 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
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 18, 2005
CompletedFirst Posted
Study publicly available on registry
August 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedDecember 7, 2012
December 1, 2012
8.3 years
August 18, 2005
December 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
During the study conduct
Secondary Outcomes (4)
Response rate
During the study conduct
Adverse events
During the study conduct
Progression-free survival
During the study conduct
Pattern of progression/relapse
During the study conduct
Study Arms (2)
1
ACTIVE COMPARATORProcedure/Surgery: A: Radiotherapy alone
2
EXPERIMENTALDrug: B: CBDCA and Radiotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
Aichi Cancer Center,Aichi Hospital
Okazaki, Aichi-ken, 444-0011, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
National Hospital Organization Shikoku Cancer Center
Natsuyama, Ehime, 790-0007, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Gifu Municipal Hospital
Gifu, Gifu, 500-8323, Japan
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550, Japan
National Nishigunma Hospital
Shibukawa, Gunma, 377-8511, Japan
National Hospital Organization, Dohoku National Hospital
Asahikawa, Hokkaido, 070-8644, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Hyogo Medical Center for Adults
Akashi, Hyōgo, 673-8558, Japan
Kobe City General Hospital
Kobe, Hyōgo, 650-0046, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501, Japan
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun, Ibaraki, 309-1793, Japan
Yokohama Mucipical Citizen's Hospital
Yokohama, Kanagawa, 240-8555, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-0815, Japan
Kumamoto Regional Medical Center Hospital
Kumamoto, Kumamoto, 860-0811, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566, Japan
Okayama University Hospital
Okayama, Okayama-ken, 700-8558, Japan
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino, Osaka, 583-8588, Japan
Rinku General Medical Center
Izumisano, Osaka, 598-0048, Japan
Osaka City General Hospital
Osaka, Osaka, 534-0021, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka, 537-8511, Japan
Graduate School of Medicine, Osaka City University
Osaka, Osaka, 545-0051, Japan
Osaka General Medical Center
Osaka, Osaka, 558-8558, Japan
Kinki University School of Medicine
Ōsaka-sayama, Osaka, 589-8511, Japan
Kinki-Chuo Chest Medical Center
Sakai, Osaka, 591-8555, Japan
National Hospital Organization Toneyama National Hospital
Toyonaka, Osaka, 560-8552, Japan
Saitama Cancer Center
Kita-adachi, Saitama, 362-0806, Japan
Sizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Cancer Institute Hospital
Koto-ku, Tokyo, 135-8550, Japan
Toranomon Hospital
Minato-ku, Tokyo, 105-8470, Japan
International Medical Center of Japan
Shinjuku-ku, Tokyo, 162-8655, Japan
Yamagata Prefectural Central Hospital
Yamagata, Yamagata, 990-2292, Japan
Related Publications (2)
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.
PMID: 29887243DERIVEDAtagi 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.
PMID: 22622008DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Masaaki Kawahawa, MD
Kinki-Chuo Chest Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2005
First Posted
August 22, 2005
Study Start
July 1, 2003
Primary Completion
November 1, 2011
Study Completion
February 1, 2012
Last Updated
December 7, 2012
Record last verified: 2012-12