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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00132665
First received: August 18, 2005
Last updated: December 6, 2012
Last verified: December 2012

August 18, 2005
December 6, 2012
July 2003
November 2011   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Overall survival
Complete list of historical versions of study NCT00132665 on ClinicalTrials.gov Archive Site
  • Response rate [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Pattern of progression/relapse [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Response rate
  • Adverse events
  • Progression-free survival
  • Pattern of progression/relapse
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small-Cell Lung Carcinoma
  • Procedure: A: Radiotherapy alone
    Procedure/Surgery: A: Radiotherapy alone
  • Drug: B: CBDCA and Radiotherapy
    Drug: B: CBDCA and Radiotherapy
  • Active Comparator: 1
    Procedure/Surgery: A: Radiotherapy alone
    Intervention: Procedure: A: Radiotherapy alone
  • Experimental: 2
    Drug: B: CBDCA and Radiotherapy
    Intervention: Drug: B: CBDCA and Radiotherapy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
February 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
71 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00132665
JCOG0301, C000000059
Yes
Japan Clinical Oncology Group
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Masaaki Kawahawa, MD Kinki-Chuo Chest Medical Center
Japan Clinical Oncology Group
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP