Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
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ClinicalTrials.gov Identifier: NCT00132665 |
Recruitment Status
:
Completed
First Posted
: August 22, 2005
Last Update Posted
: December 7, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small-Cell Lung Carcinoma | Procedure: A: Radiotherapy alone Drug: B: CBDCA and Radiotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
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) |
Study Start Date : | July 2003 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | February 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Procedure/Surgery: A: Radiotherapy alone
|
Procedure: A: Radiotherapy alone
Procedure/Surgery: A: Radiotherapy alone
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Experimental: 2
Drug: B: CBDCA and Radiotherapy
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Drug: B: CBDCA and Radiotherapy
Drug: B: CBDCA and Radiotherapy
|
- Overall survival [ Time Frame: During the study conduct ]
- 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 ]

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Ages Eligible for Study: | 71 Years and older (Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00132665
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 |
Study Chair: | Masaaki Kawahawa, MD | Kinki-Chuo Chest Medical Center |
Additional Information:
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 ( Registry Identifier: UMIN-CTR ) |
First Posted: | August 22, 2005 Key Record Dates |
Last Update Posted: | December 7, 2012 |
Last Verified: | December 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 |