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

December 6, 2012 updated by: Japan Clinical Oncology Group

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

71 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: During the study conduct
During the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: During the study conduct
During the study conduct
Progression-free survival
Time Frame: During the study conduct
During the study conduct
Response rate
Time Frame: During the study conduct
During the study conduct
Pattern of progression/relapse
Time Frame: During the study conduct
During the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Masaaki Kawahawa, MD, Kinki-Chuo Chest Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 7, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0301
  • C000000059 (Registry Identifier: UMIN-CTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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