Small-Cell-Lung CancerPhase 3NCT00144989
A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
A Phase 3 study testing Etoposide and cisplatin after chemoradiotherapy and Irinotecan and cisplatin after chemoradiotherapy in people with Small-Cell-Lung Cancer, run by Haruhiko Fukuda at 37 sites in Japan.
Trial summary
To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Small-Cell-Lung Cancer
- What is being tested?
- Etoposide and cisplatin after chemoradiotherapy and Irinotecan and cisplatin after chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 37 sitesJapan
- Study dates
- Sep 2002to Sep 2011
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cytologically, histologically proven small-cell lung cancer
- limited disease
- age 20-70 years old
- performance status of 0-1
- measurable disease
- no prior treatment for small-cell lung cancer
Show all 9Show fewer
- no history of chemotherapy
- adequate organ functions
- written informed consent
Who cannot join
- pericardial effusion
- active concomitant malignancy
- pregnant or lactating women
- interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Japan37 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
Rinku General Medical Center
Izumisano,rinku-ohrai-kita,2-23, Osaka, 598-0048
National Cancer Center Hospital East
Kashiwa-shi,Kashiwanoha,6-5-1, Chiba, 277-8577
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806
Kobe City General Hospital
Kobe,Chuo-ku,Minatojimanakamachi,4-6, Hyōgo, 650-0046
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, 135-8550
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
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, 105-8470
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
Okayama University Hospital
Okayama,Shikata-cho,2-5-1, Okayama-ken, 700-8558
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
Graduate School of Medicine, Osaka City University
Osaka,Abeno-ku,Asahi-machi,1-5-7, Osaka, 545-0051
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
Osaka General Medical Center
Osaka,Sumiyoshi-ku,Bandai-higashi,3-1-56, Osaka, 558-8558
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
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-0874
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: A Phase III Study Comparing Etoposide and Cisplatin (EP) With Irinotecan and Cisplatin (IP) Following EP Plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for Limited-Stage Small-Cell Lung Cancer : JCOG0202-MF
To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.
Read the detailed description
The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The response rate and overall median survival were significantly better for IP, i.e. 84.4% and 12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore the use of IP in LSCLC.
- Conditions
- Small-Cell-Lung Cancer
- Being tested
- Etoposide and cisplatin after chemoradiotherapy, Irinotecan and cisplatin after chemoradiotherapy
- Keywords
- Small-cell lung cancer, Limited-Stage Small-Cell Lung Cancer, Combined modality therapy, chemotherapy, radiotherapy, Irinotecan, Cisplatin
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etoposide and cisplatin after chemoradiotherapyDrug
Etoposide and cisplatin after chemoradiotherapy
Irinotecan and cisplatin after chemoradiotherapyDrug
Irinotecan and cisplatin after chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Etoposide and cisplatin after chemoradiotherapy Receives: Drug: Etoposide and cisplatin after chemoradiotherapy |
| 2 | Experimental | Irinotecan and cisplatin after chemoradiotherapy Receives: Drug: Irinotecan and cisplatin after chemoradiotherapy |
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 (5)
adverse events of induction chemoradiotherapy
Measured: during the study conduct
chemotherapy after chemoradiotherapy
Measured: during the study conduct
late radiation morbidity
Measured: during the study conduct
serious adverse event
Measured: during the study conduct
progression-free survival
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 posted5 Sep 2005 (estimated)
- Study startSep 2002
- Primary completionSep 2011
- Study completionSep 2011
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 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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haruhiko Fukuda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor-investigator, Haruhiko Fukuda, Japan Clinical Oncology Group
- Investigators
- Yutaka Nishiwaki, MD, Study chair, National Cancer Center Hospital East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144989
- Sponsor's protocol ID
- JCOG0202-MF
- Other IDs
- C000000095
- Status last verified
- Sep 2016
- First submitted
- 1 Sep 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kubota K, Hida T, Ishikura S, Mizusawa J, Nishio M, Kawahara M, Yokoyama A, Imamura F, Takeda K, Negoro S, Harada M, Okamoto H, Yamamoto N, Shinkai T, Sakai H, Matsui K, Nakagawa K, Shibata T, Saijo N, Tamura T; Japan Clinical Oncology Group. Etoposide and cisplatin versus irinotecan and cisplatin in patients with limited-stage small-cell lung cancer treated with etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic radiotherapy (JCOG0202): a randomised phase 3 study. Lancet Oncol. 2014 Jan;15(1):106-13. doi: 10.1016/S1470-2045(13)70511-4. Epub 2013 Dec 3.
PubMed 24309370
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study Comparing Etoposide and Cisplatin (EP) With Irinotecan and Cisplatin (IP) Following EP Plus Concurrent Accelerated Hyperfractionated Thoracic Irradiation (EP/TRT) for Limited-Stage Small-Cell Lung Cancer : JCOG0202-MF
- ClinicalTrials.gov ID
- NCT00144989
- Acronym / sponsor ID
- JCOG0202-MF
- Conditions
- Small-Cell-Lung Cancer
- Keywords
- Small-cell lung cancer, Limited-Stage Small-Cell Lung Cancer, Combined modality therapy, chemotherapy, radiotherapy, Irinotecan, Cisplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Haruhiko FukudaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Sep 2002
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 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 role of 3 cycles of irinotecan and cisplatin for patients with limited-stage small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic irradiation.
Detailed description
The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The response rate and overall median survival were significantly better for IP, i.e. 84.4% and 12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore the use of IP in LSCLC.
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 | Drug: Etoposide and cisplatin after chemoradiotherapyEtoposide and cisplatin after chemoradiotherapy |
| 2 | Experimental | Drug: Irinotecan and cisplatin after chemoradiotherapyIrinotecan and cisplatin after chemoradiotherapy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- cytologically, histologically proven small-cell lung cancer
- limited disease
- age 20-70 years old
- performance status of 0-1
- measurable disease
Key exclusion criteria (4 listed)
- pericardial effusion
- active concomitant malignancy
- pregnant or lactating women
- interstitial pneumonia/active lung fibrosis on chest x-ray, watery diarrhea, intestinal obstruction or paralysis, uncontrolled heart disease or a history of myocardial infarction within the previous 6 months, uncontrolled diabetes mellitus, active infection, psychological disease deemed unacceptable for inclusion to the study, long-term steroid treatment.
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 |
|---|---|---|
| Etoposide and cisplatin after chemoradiotherapyEtoposide and cisplatin after chemoradiotherapy | Drug | 1 |
| Irinotecan and cisplatin after chemoradiotherapyIrinotecan and cisplatin after chemoradiotherapy | Drug | 2 |
Primary outcome
overall survival
Time frame: during the study conduct
5 secondary outcomes
adverse events of induction chemoradiotherapy
Time frame: during the study conduct
chemotherapy after chemoradiotherapy
Time frame: during the study conduct
late radiation morbidity
Time frame: during the study conduct
serious adverse event
Time frame: during the study conduct
progression-free survival
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 22 Sep 2016.
- Derived from this study: PubMed 24309370Kubota K, Hida T, Ishikura S, Mizusawa J, Nishio M, Kawahara M, Yokoyama A, Imamura F, Takeda K, Negoro S, Harada M, Okamoto H, Yamamoto N, Shinkai T, Sakai H, Matsui K, Nakagawa K, Shibata T, Saijo N, Tamura T; Japan Clinical Oncology Group. Etoposide and cisplatin versus irinotecan and cisplatin in patients with limited-stage small-cell lung cancer treated with etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic radiotherapy (JCOG0202): a randomised phase 3 study. Lancet Oncol. 2014 Jan;15(1):106-13. doi: 10.1016/S1470-2045(13)70511-4. Epub 2013 Dec 3.
- 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.
Yutaka Nishiwaki, MD study chair
National Cancer Center Hospital East
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 Etoposide and cisplatin after chemoradiotherapy and Irinotecan and cisplatin after chemoradiotherapy in people with Small-Cell-Lung Cancer, run by Haruhiko Fukuda 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 9 inclusion and 4 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 22 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 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 NCT00144989, 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 22 Sep 2016.