Clinical trial NCT00132665: Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: non-small cell lung cancer
elderly patients
carboplatin
chemoradiotherapy
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2005-08-22
Enrollment: 200
Sex: ALL
Minimum age (years): 71
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: During the study conduct
Secondary outcomes:
measure: Response rate
timeFrame: During the study conduct
measure: Adverse events
timeFrame: During the study conduct
measure: Progression-free survival
timeFrame: During the study conduct
measure: Pattern of progression/relapse
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Okazaki
country: Japan
facility: Aichi Cancer Center,Aichi Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Natsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Ehime
city: Ota
country: Japan
facility: Gunma Prefectural Cancer Center
state: Gunma
city: Shibukawa
country: Japan
facility: National Nishigunma Hospital
state: Gunma
city: Asahikawa
country: Japan
facility: National Hospital Organization, Dohoku National Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Akashi
country: Japan
facility: Hyogo Medical Center for Adults
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City General Hospital
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
state: Hyogo
city: Nishi-ibarakigun
country: Japan
facility: Ibaraki Kenritsu Chuo Hospital & Cancer Center
state: Ibaraki
city: Yokohama
country: Japan
facility: Yokohama Mucipical Citizen's Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Habikino
country: Japan
facility: Osaka Prefectural Medical Center for Respiratory and Allergic Disease
state: Osaka
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Osaka-Sayama
country: Japan
facility: Kinki University School of Medicine
state: Osaka
city: Sakai
country: Japan
facility: Kinki-Chuo Chest Medical Center
state: Osaka
city: Toyonaka
country: Japan
facility: National Hospital Organization Toneyama National Hospital
state: Osaka
city: Kita-adachi
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Sunto-gun
country: Japan
facility: Sizuoka Cancer Center
state: Shizuoka
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: International Medical Center of Japan
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Regional Medical Center Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
city: Osaka
country: Japan
facility: Graduate School of Medicine, Osaka City University
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
Study officials:
affiliation: Kinki-Chuo Chest Medical Center
name: Masaaki Kawahawa, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.