Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)

Non-Small-Cell Lung Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132665
• Other study ID #: JCOG0301
• Secondary ID: C000000059
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2005
• Last updated: December 6, 2012
• Start date: July 2003
• Est. completion date: February 2012

Study information

• Verified date: December 2012
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 71 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

Procedure:
• A: Radiotherapy alone
Procedure/Surgery: A: Radiotherapy alone

Drug:
• B: CBDCA and Radiotherapy
Drug: B: CBDCA and Radiotherapy

Locations

Country	Name	City	State
Japan	Hyogo Medical Center for Adults	Akashi	Hyogo
Japan	National Hospital Organization, Dohoku National Hospital	Asahikawa	Hokkaido
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Kyushu University Hospital	Fukuoka
Japan	Gifu Municipal Hospital	Gifu
Japan	Osaka Prefectural Medical Center for Respiratory and Allergic Disease	Habikino	Osaka
Japan	Rinku General Medical Center	Izumisano	Osaka
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	Saitama Cancer Center	Kita-adachi	Saitama
Japan	Kobe City General Hospital	Kobe	Hyogo
Japan	Cancer Institute Hospital	Koto-ku	Tokyo
Japan	Kumamoto Regional Medical Center Hospital	Kumamoto
Japan	Toranomon Hospital	Minato-ku	Tokyo
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	National Hospital Organization Shikoku Cancer Center	Natsuyama	Ehime
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Ibaraki Kenritsu Chuo Hospital & Cancer Center	Nishi-ibarakigun	Ibaraki
Japan	Hyogo College of Medicine	Nishinomiya	Hyogo
Japan	Okayama University Hospital	Okayama
Japan	Aichi Cancer Center,Aichi Hospital	Okazaki	Aichi
Japan	Graduate School of Medicine, Osaka City University	Osaka
Japan	Osaka City General Hospital	Osaka
Japan	Osaka General Medical Center	Osaka
Japan	Osaka Medical Center for Cancer and Cardiovascular Diseases	Osaka
Japan	Kinki University School of Medicine	Osaka-Sayama	Osaka
Japan	Gunma Prefectural Cancer Center	Ota	Gunma
Japan	Kinki-Chuo Chest Medical Center	Sakai	Osaka
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	National Nishigunma Hospital	Shibukawa	Gunma
Japan	International Medical Center of Japan	Shinjuku-ku	Tokyo
Japan	Sizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	National Hospital Organization Toneyama National Hospital	Toyonaka	Osaka
Japan	Tochigi Cancer Center	Utsunomiya	Tochigi
Japan	Yamagata Prefectural Central Hospital	Yamagata
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa
Japan	Yokohama Mucipical Citizen's Hospital	Yokohama	Kanagawa

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		During the study conduct	No
Secondary	Response rate		During the study conduct	No
Secondary	Adverse events		During the study conduct	Yes
Secondary	Progression-free survival		During the study conduct	No
Secondary	Pattern of progression/relapse		During the study conduct	No

External Links

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