Non-small-cell Lung CancerPhase 3NCT00190476
Elderly NSCLC/D vs DP (JCOG0207)
A Phase 3 study testing Weekly docetaxel alone and Weekly docetaxel + cisplatin combination in people with Non-small-cell Lung Cancer, run by Japan Clinical Oncology Group at 29 sites in Japan.
Trial summary
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- Weekly docetaxel alone and Weekly docetaxel + cisplatin combination
- How many people
- 230 participants
- Where
- 29 sitesJapan
- Study dates
- Apr 2003to Apr 2007
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- histologically or cytologically proven non-small-cell lung cancer
- stage IV, or stage III disease ineligible for definitive radiotherapy
- 70 years or older
- ECOG PS 0-1
- Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
- No prior chemotherapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
Show all 11Show fewer
- No prior surgery within 4 weeks before enrollment
- No prior radiotherapy for primary tumor
- No prior radiotherapy for metastatic lesions within 2 weeks before enrollment
- Adequate organ function
- Signed informed consent
Who cannot join
- Symptomatic brain metastasis
- Active another neoplasms
- Severe SVC syndrome
- Massive pericardial, pleural effusion, or ascites
- Bone metastasis emergent for palliative radiotherapy or surgery
- Uncontrollable systemic hypertension
Show all 12Show fewer
- Heart failure, Unstable angina, Myocardial infarction within 6 months
- Uncontrollable diabetes
- Active infection
- Interstitial pneumonia/ Pulmonary fibrosis
- Hypersensitivity for polysorbate 80
- Systemic administration of corticosteroids
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
Hyogo Medical Center for Adults
Akashi,Kitaouji-cho,13-70, Hyōgo, 673-8558
National Hospital Organization, Dohoku National Hospital
Asahikawa,Hanasaki,7-4048, Hokkaido, 070-8644
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, 500-8323
Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Habikino,Habikino,3-7-1, Osaka, 583-8588
Kyushu University Hospital
Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806
Kumamoto Regional Medical Center Hospital
Kumamoto,Honjo,5-16-10, Kumamoto, 860-0811
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho, 2-15-3, Niigata, 951-8566
Ibaraki Kenritsu Chuo Hospital & Cancer Center
Nishi-ibarakigun,Tomobemachi,Koibuchi,6528, Ibaraki, 309-1793
Hyogo College of Medicine
Nishinomiya,Mukogawa-cho,1-1, Hyōgo, 663-8501
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, 444-0011
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511
Osaka City General Hospital
Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021
Gunma Prefectural Cancer Center
Ota,Takabayashi-nishi-cho,617-1, Gunma, 373-8550
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai,Nagasone,1180, Osaka, 591-8555
National Hospital Organization Hokkaido Cancer Center
Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, 003-0804
National Nishigunma Hospital
Shibukawa,Kanai,2854, Gunma, 377-8511
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777
National Hospital Organization Toneyama National Hospital
Toyonaka,Toneyama,5-1-1, Osaka, 560-8552
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, 990-2292
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815
Yokohama Mucipical Citizen's Hospital
Yokohama,Hodogaya-ku,Okazawa-cho,56, Kanagawa, 240-8555
About this study
Official title: Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Read the detailed description
The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination.
Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- Weekly docetaxel alone, Weekly docetaxel + cisplatin combination
- Keywords
- Elderly, advanced, non-small-cell lung cancer, cisplatin, docetaxel, weekly, combination, chemotherapy, randomized trial
- 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.
Weekly docetaxel aloneDrug
Weekly docetaxel + cisplatin combinationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Secondary outcomes (4)
Toxicity
Progression-free survival
Response rate
Symptom score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startApr 2003
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small-cell Lung CancerStudies 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
- 230 participants
Sponsor and investigators
- Lead sponsor
- Japan Clinical Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Investigators
- Akira Yokoyama, MD, PhD, Study chair, Department of Internal Medicine, Niigata Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190476
- Sponsor's protocol ID
- JCOG0207
- Other IDs
- C000000146
- Status last verified
- Sep 2016
- First submitted
- 11 Sep 2005
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsukada H, Yokoyama A, Goto K, Shinkai T, Harada M, Ando M, Shibata T, Ohe Y, Tamura T, Saijo N; Lung Cancer Study Group of the Japan Clinical Oncology Group (JCOG). Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207dagger. Jpn J Clin Oncol. 2015 Jan;45(1):88-95. doi: 10.1093/jjco/hyu176. Epub 2014 Nov 6.
PubMed 25378648
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Docetaxel-cisplatin Combination With Docetaxel Alone in Elderly Patients With Advanced Non-small-cell Lung Cancer(JCOG0207)
- ClinicalTrials.gov ID
- NCT00190476
- Acronym / sponsor ID
- JCOG0207
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- Elderly, advanced, non-small-cell lung cancer, cisplatin, docetaxel, weekly, combination, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 230 participants
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Apr 2003
- Study completion
- Apr 2007
- First posted
- 19 Sep 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.
To evaluate the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Detailed description
The Elderly Lung Cancer Vinorelbine Italian Study demonstrated the first evidence of the utility of chemotherapy in elderly patients with advanced non-small-cell lung cancer (NSCLC). In a large randomized trial, gemcitabine and vinorelbine failed to show any advantage over either agent alone. With the current evidence, single agent chemotherapy with a third-generation drug can be considered a recommended option for elderly patients with advanced NSCLC. A Japanese phase I/II study showed the activity (overall response rate 52%, median survival 12.4 months) and tolerability of weekly docetaxel/ cisplatin combination in patients older than age 75 years. There have been no randomized prospective trials dedicated to elderly NSCLC patients to evaluate tolerability and efficacy of platinum-based combination.
Comparison: Single-agent weekly docetaxel versus weekly regimen of docetaxel-cisplatin combination for elderly advanced NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- histologically or cytologically proven non-small-cell lung cancer
- stage IV, or stage III disease ineligible for definitive radiotherapy
- 70 years or older
- ECOG PS 0-1
- Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
Key exclusion criteria (12 listed)
- Symptomatic brain metastasis
- Active another neoplasms
- Severe SVC syndrome
- Massive pericardial, pleural effusion, or ascites
- Bone metastasis emergent for palliative radiotherapy or surgery
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 |
|---|---|---|
| Weekly docetaxel alone | Drug | – |
| Weekly docetaxel + cisplatin combination | Drug | – |
Primary outcome
overall survival
4 secondary outcomes
Toxicity
Progression-free survival
Response rate
Symptom score
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2016.
- Derived from this study: PubMed 25378648Tsukada H, Yokoyama A, Goto K, Shinkai T, Harada M, Ando M, Shibata T, Ohe Y, Tamura T, Saijo N; Lung Cancer Study Group of the Japan Clinical Oncology Group (JCOG). Randomized controlled trial comparing docetaxel-cisplatin combination with weekly docetaxel alone in elderly patients with advanced non-small-cell lung cancer: Japan Clinical Oncology Group (JCOG) 0207dagger. Jpn J Clin Oncol. 2015 Jan;45(1):88-95. doi: 10.1093/jjco/hyu176. Epub 2014 Nov 6.
- Related InfoLink provided by the sponsor.
Related trials for Non-small-cell Lung Cancer
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
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.
Akira Yokoyama, MD, PhD study chair
Department of Internal Medicine, Niigata Cancer Center Hospital
29 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 Weekly docetaxel alone and Weekly docetaxel + cisplatin combination in people with Non-small-cell Lung Cancer, run by Japan Clinical Oncology Group at 29 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 12 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: stopped early, as of the sponsor's last update on 12 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 was stopped early. Results are not available in the source record.
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. 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 NCT00190476, which also lists 1 linked publication.
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 12 Sep 2016.