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

Primary Purpose

Non-Small-Cell Lung Carcinoma

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
A: Radiotherapy alone
B: CBDCA and Radiotherapy
Sponsored by
Japan Clinical Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Carcinoma focused on measuring non-small cell lung cancer, elderly patients, carboplatin, chemoradiotherapy

Eligibility Criteria

71 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aichi Cancer Center Hospital
  • Aichi Cancer Center,Aichi Hospital
  • National Cancer Center Hospital East
  • National Hospital Organization Shikoku Cancer Center
  • Gunma Prefectural Cancer Center
  • National Nishigunma Hospital
  • National Hospital Organization, Dohoku National Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Hyogo Medical Center for Adults
  • Kobe City General Hospital
  • Hyogo College of Medicine
  • Ibaraki Kenritsu Chuo Hospital & Cancer Center
  • Yokohama Mucipical Citizen's Hospital
  • Kanagawa Cancer Center
  • Tohoku University Hospital
  • Osaka Prefectural Medical Center for Respiratory and Allergic Disease
  • Rinku General Medical Center
  • Kinki University School of Medicine
  • Kinki-Chuo Chest Medical Center
  • National Hospital Organization Toneyama National Hospital
  • Saitama Cancer Center
  • Sizuoka Cancer Center
  • Tochigi Cancer Center
  • National Cancer Center Hospital
  • Cancer Institute Hospital
  • Toranomon Hospital
  • International Medical Center of Japan
  • Kyushu University Hospital
  • Gifu Municipal Hospital
  • Kumamoto Regional Medical Center Hospital
  • Niigata Cancer Center Hospital
  • Okayama University Hospital
  • Osaka City General Hospital
  • Osaka Medical Center for Cancer and Cardiovascular Diseases
  • Graduate School of Medicine, Osaka City University
  • Osaka General Medical Center
  • Yamagata Prefectural Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Procedure/Surgery: A: Radiotherapy alone

Drug: B: CBDCA and Radiotherapy

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Response rate
Adverse events
Progression-free survival
Pattern of progression/relapse

Full Information

First Posted
August 18, 2005
Last Updated
December 6, 2012
Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00132665
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Japan Clinical Oncology Group
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Carcinoma
Keywords
non-small cell lung cancer, elderly patients, carboplatin, chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: A: Radiotherapy alone
Arm Title
2
Arm Type
Experimental
Arm Description
Drug: B: CBDCA and Radiotherapy
Intervention Type
Procedure
Intervention Name(s)
A: Radiotherapy alone
Intervention Description
Procedure/Surgery: A: Radiotherapy alone
Intervention Type
Drug
Intervention Name(s)
B: CBDCA and Radiotherapy
Intervention Description
Drug: B: CBDCA and Radiotherapy
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
During the study conduct
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
During the study conduct
Title
Adverse events
Time Frame
During the study conduct
Title
Progression-free survival
Time Frame
During the study conduct
Title
Pattern of progression/relapse
Time Frame
During the study conduct

10. Eligibility

Sex
All
Minimum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaaki Kawahawa, MD
Organizational Affiliation
Kinki-Chuo Chest Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Aichi Cancer Center,Aichi Hospital
City
Okazaki
State/Province
Aichi
ZIP/Postal Code
444-0011
Country
Japan
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Natsuyama
State/Province
Ehime
ZIP/Postal Code
790-0007
Country
Japan
Facility Name
Gunma Prefectural Cancer Center
City
Ota
State/Province
Gunma
ZIP/Postal Code
373-8550
Country
Japan
Facility Name
National Nishigunma Hospital
City
Shibukawa
State/Province
Gunma
ZIP/Postal Code
377-8511
Country
Japan
Facility Name
National Hospital Organization, Dohoku National Hospital
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo Medical Center for Adults
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Facility Name
Kobe City General Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0046
Country
Japan
Facility Name
Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Ibaraki Kenritsu Chuo Hospital & Cancer Center
City
Nishi-ibarakigun
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Yokohama Mucipical Citizen's Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
240-8555
Country
Japan
Facility Name
Kanagawa Cancer Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
City
Habikino
State/Province
Osaka
ZIP/Postal Code
583-8588
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Facility Name
Kinki University School of Medicine
City
Osaka-Sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Kinki-Chuo Chest Medical Center
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
National Hospital Organization Toneyama National Hospital
City
Toyonaka
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Saitama Cancer Center
City
Kita-adachi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Sizuoka Cancer Center
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Toranomon Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
International Medical Center of Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu
ZIP/Postal Code
500-8323
Country
Japan
Facility Name
Kumamoto Regional Medical Center Hospital
City
Kumamoto
ZIP/Postal Code
860-0811
Country
Japan
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Osaka Medical Center for Cancer and Cardiovascular Diseases
City
Osaka
ZIP/Postal Code
537-8511
Country
Japan
Facility Name
Graduate School of Medicine, Osaka City University
City
Osaka
ZIP/Postal Code
545-0051
Country
Japan
Facility Name
Osaka General Medical Center
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata
ZIP/Postal Code
990-2292
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29887243
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.
Results Reference
derived
PubMed Identifier
22622008
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.
Results Reference
derived
Links:
URL
http://www.jcog.jp/
Description
Related Info

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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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