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

Purpose

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	Intervention	Phase
Non-Small-Cell Lung Carcinoma	Procedure: A: Radiotherapy alone Drug: B: CBDCA and Radiotherapy	Phase 3


Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

Overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures:

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


Enrollment:	200
Study Start Date:	July 2003
Study Completion Date:	February 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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

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.


Responsible Party:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00132665 History of Changes
Other Study ID Numbers:	JCOG0301 C000000059 ( Registry Identifier: UMIN-CTR )
Study First Received:	August 18, 2005
Last Updated:	December 6, 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

ClinicalTrials.gov processed this record on August 21, 2017