Non-Small-Cell Lung CarcinomaPhase 3NCT00132665
Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)
A Phase 3 study testing A: Radiotherapy alone and B: CBDCA and Radiotherapy in people with Non-Small-Cell Lung Carcinoma, run by Japan Clinical Oncology Group at 37 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 71 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- A: Radiotherapy alone and B: CBDCA and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 37 sitesJapan
- Study dates
- Jul 2003to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 71 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Japan37 sites
Hyogo Medical Center for Adults
Akashi, Hyōgo, 673-8558
National Hospital Organization, Dohoku National Hospital
Asahikawa, Hokkaido, 070-8644
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
Gifu Municipal Hospital
Gifu, Gifu, 500-8323
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino, Osaka, 583-8588
Rinku General Medical Center
Izumisano, Osaka, 598-0048
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Saitama Cancer Center
Kita-adachi, Saitama, 362-0806
Kobe City General Hospital
Kobe, Hyōgo, 650-0046
Cancer Institute Hospital
Koto-ku, Tokyo, 135-8550
Kumamoto Regional Medical Center Hospital
Kumamoto, Kumamoto, 860-0811
Toranomon Hospital
Minato-ku, Tokyo, 105-8470
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
National Hospital Organization Shikoku Cancer Center
Natsuyama, Ehime, 790-0007
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun, Ibaraki, 309-1793
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501
Okayama University Hospital
Okayama, Okayama-ken, 700-8558
Aichi Cancer Center,Aichi Hospital
Okazaki, Aichi-ken, 444-0011
Osaka City General Hospital
Osaka, Osaka, 534-0021
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka, 537-8511
Graduate School of Medicine, Osaka City University
Osaka, Osaka, 545-0051
Osaka General Medical Center
Osaka, Osaka, 558-8558
Kinki University School of Medicine
Ōsaka-sayama, Osaka, 589-8511
Gunma Prefectural Cancer Center
Ōta, Gunma, 373-8550
Kinki-Chuo Chest Medical Center
Sakai, Osaka, 591-8555
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Tohoku University Hospital
Sendai, Miyagi, 980-8574
National Nishigunma Hospital
Shibukawa, Gunma, 377-8511
International Medical Center of Japan
Shinjuku-ku, Tokyo, 162-8655
Sizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
National Hospital Organization Toneyama National Hospital
Toyonaka, Osaka, 560-8552
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834
Yamagata Prefectural Central Hospital
Yamagata, Yamagata, 990-2292
Yokohama Mucipical Citizen's Hospital
Yokohama, Kanagawa, 240-8555
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-0815
About this study
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)
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.
Read the 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.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- A: Radiotherapy alone, B: CBDCA and Radiotherapy
- Keywords
- non-small cell lung cancer, elderly patients, carboplatin, chemoradiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: Radiotherapy aloneProcedure or surgery
Procedure/Surgery: A: Radiotherapy alone
B: CBDCA and RadiotherapyDrug
Drug: B: CBDCA and Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Procedure/Surgery: A: Radiotherapy alone Receives: Procedure: A: Radiotherapy alone |
| 2 | Experimental | Drug: B: CBDCA and Radiotherapy Receives: Drug: B: CBDCA and Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: During the study conduct
Secondary outcomes (4)
Response rate
Measured: During the study conduct
Adverse events
Measured: During the study conduct
Progression-free survival
Measured: During the study conduct
Pattern of progression/relapse
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startJul 2003
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Clinical Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor
- Investigators
- Masaaki Kawahawa, MD, Study chair, Kinki-Chuo Chest Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132665
- Sponsor's protocol ID
- JCOG0301
- Other IDs
- C000000059
- Status last verified
- Dec 2012
- First submitted
- 18 Aug 2005
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29887243Atagi 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.
PubMed 22622008
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00132665
- Acronym / sponsor ID
- JCOG0301
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- non-small cell lung cancer, elderly patients, carboplatin, chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Jul 2003
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: A: Radiotherapy aloneProcedure/Surgery: A: Radiotherapy alone |
| 2 | Experimental | Drug: B: CBDCA and RadiotherapyDrug: B: CBDCA and Radiotherapy |
Who may qualify
- Ages
- 71 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A: Radiotherapy aloneProcedure/Surgery: A: Radiotherapy alone | Procedure or surgery | 1 |
| B: CBDCA and RadiotherapyDrug: B: CBDCA and Radiotherapy | Drug | 2 |
Primary outcome
Overall survival
Time frame: During the study conduct
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
- Derived from this study: PubMed 29887243Atagi 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.
- Derived from this study: PubMed 22622008Atagi 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaaki Kawahawa, MD study chair
Kinki-Chuo Chest Medical Center
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing A: Radiotherapy alone and B: CBDCA and Radiotherapy in people with Non-Small-Cell Lung Carcinoma, run by Japan Clinical Oncology Group at 37 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: During the study conduct). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2012.