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
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 General Medical Center | |
| Osaka, Japan, 558-8558 | |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | |
| Osaka, Japan, 537-8511 | |
| Graduate School of Medicine, Osaka City University | |
| Osaka, Japan, 545-0051 | |
| Osaka City General Hospital | |
| Osaka, Japan, 534-0021 | |
| 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 Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013