Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
This study has been completed.
Sponsor:
Japan Clinical Oncology Group
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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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:
Further study details as provided by Japan Clinical Oncology Group:
Primary Outcome Measures:
- Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
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 | |
| Kanagawa Cancer Center | |
| Yokohama, Kanagawa, Japan, 241-0815 | |
| Yokohama Mucipical Citizen's Hospital | |
| Yokohama, Kanagawa, Japan, 240-8555 | |
| 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 Medical Center for Cancer and Cardiovascular Diseases | |
| Osaka, Japan, 537-8511 | |
| Osaka City General Hospital | |
| Osaka, Japan, 534-0021 | |
| Osaka General Medical Center | |
| Osaka, Japan, 558-8558 | |
| Graduate School of Medicine, Osaka City University | |
| Osaka, Japan, 545-0051 | |
| 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:
No publications provided by Japan Clinical Oncology Group
Additional 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 |
| Study First Received: | August 18, 2005 |
| Last Updated: | December 6, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Oncology Group:
|
non-small cell lung cancer elderly patients carboplatin chemoradiotherapy Non-small cell Lung Cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms |
ClinicalTrials.gov processed this record on March 03, 2015