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

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ClinicalTrials.gov Identifier: NCT00132665
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : December 7, 2012
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Japan Clinical Oncology Group

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Procedure: A: Radiotherapy alone Drug: B: CBDCA and Radiotherapy Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2003
Actual Primary Completion Date : November 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Procedure/Surgery: A: Radiotherapy alone
 Procedure: A: Radiotherapy alone
Procedure/Surgery: A: Radiotherapy alone
Experimental: 2
Drug: B: CBDCA and Radiotherapy
 Drug: B: CBDCA and Radiotherapy
Drug: B: CBDCA and Radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: During the study conduct ]
  2. Adverse events [ Time Frame: During the study conduct ]
  3. Progression-free survival [ Time Frame: During the study conduct ]
  4. Pattern of progression/relapse [ Time Frame: During the study conduct ]

Eligibility Criteria
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Ages Eligible for Study:   71 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132665


Locations
Japan
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
Aichi Cancer Center,Aichi Hospital
Okazaki, Aichi, Japan, 444-0011
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Natsuyama, Ehime, Japan, 790-0007
Gunma Prefectural Cancer Center
Ota, Gunma, Japan, 373-8550
National Nishigunma Hospital
Shibukawa, Gunma, Japan, 377-8511
National Hospital Organization, Dohoku National Hospital
Asahikawa, Hokkaido, Japan, 070-8644
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
Hyogo Medical Center for Adults
Akashi, Hyogo, Japan, 673-8558
Kobe City General Hospital
Kobe, Hyogo, Japan, 650-0046
Hyogo College of Medicine
Nishinomiya, Hyogo, Japan, 663-8501
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun, Ibaraki, Japan, 309-1793
Yokohama Mucipical Citizen's Hospital
Yokohama, Kanagawa, Japan, 240-8555
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-0815
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino, Osaka, Japan, 583-8588
Rinku General Medical Center
Izumisano, Osaka, Japan, 598-0048
Kinki University School of Medicine
Osaka-Sayama, Osaka, Japan, 589-8511
Kinki-Chuo Chest Medical Center
Sakai, Osaka, Japan, 591-8555
National Hospital Organization Toneyama National Hospital
Toyonaka, Osaka, Japan, 560-8552
Saitama Cancer Center
Kita-adachi, Saitama, Japan, 362-0806
Sizuoka Cancer Center
Sunto-gun, Shizuoka, Japan, 411-8777
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan, 320-0834
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Cancer Institute Hospital
Koto-ku, Tokyo, Japan, 135-8550
Toranomon Hospital
Minato-ku, Tokyo, Japan, 105-8470
International Medical Center of Japan
Shinjuku-ku, Tokyo, Japan, 162-8655
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Gifu Municipal Hospital
Gifu, Japan, 500-8323
Kumamoto Regional Medical Center Hospital
Kumamoto, Japan, 860-0811
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
Okayama University Hospital
Okayama, Japan, 700-8558
Osaka City General Hospital
Osaka, Japan, 534-0021
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 537-8511
Graduate School of Medicine, Osaka City University
Osaka, Japan, 545-0051
Osaka General Medical Center
Osaka, Japan, 558-8558
Yamagata Prefectural Central Hospital
Yamagata, Japan, 990-2292
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Masaaki Kawahawa, MD Kinki-Chuo Chest Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00132665     History of Changes
Other Study ID Numbers: JCOG0301
C000000059 ( Registry Identifier: UMIN-CTR )
First Posted: August 22, 2005    Key Record Dates
Last Update Posted: December 7, 2012
Last Verified: December 2012

Keywords provided by Japan Clinical Oncology Group:
non-small cell lung cancer
elderly patients
carboplatin
chemoradiotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Antineoplastic Agents