Small Cell Lung CancerPhase 3NCT00349492
A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer
A Phase 3 study testing IP in people with Small Cell Lung Cancer, run by Clinical Research Center for Solid Tumor, Korea at 14 sites in South Korea.
Trial summary
This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms. Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- IP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Jun 2006to Oct 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically diagnosed small cell lung cancer
- Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion)
- If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)
- No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy)
- One or more measurable disease by RECIST criteria
- at least 18 years of age
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- Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria
- Adequate hematologic (neutrophil count >= 1,500/uL, platelets >= 100,000/uL), hepatic (transaminase =< upper normal limit(UNL)x2.5, bilirubin level =< UNLx1.5), and renal (creatinine =< UNL) function
- Informed consent from patient which conforms to Institutional Review Board
Who cannot join
- History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years
- Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
- Uncontrolled serious infection
- Enrollment in other study within 30 days
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si, 420-767
Yeungnam University Hospital
Daegu, 705-717
Daegu Catholic University Hospital
Daegu, 705-718
Gyeongsang National University Hospital
Jinju, 660-702
Seoul National University Bundang Hospital
Seongnam-si, 463-707
Seoul National University Hospital
Seoul, 110-744
Kangbuk Samsung Hospital
Seoul, 110-746
Yonsei Cancer Center
Seoul, 120-752
Seoul Veterans Hospital
Seoul, 134-791
Kangnam St.Mary's Hospital
Seoul, 137-040
Asan Medical Center
Seoul, 138-736
Chung-Ang University Medical Center
Seoul, 151-756
Seoul Municipal Boramae Hospital
Seoul, 156-707
St.Vincent Hospital
Suwon, 422-723
About this study
Official title: Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC)
This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms.
Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks
Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years
- Conditions
- Small Cell Lung Cancer
- Being tested
- IP
- Keywords
- Small Cell Lung Cancer, Extensive Disease, Chemotherapy, Randomisation
- 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.
IPDrug
Also called irinotecan + cisplatin
irinotecan+cisplatin
| Study group | Role | What they receive |
|---|---|---|
| EP | Active comparator | etoposide + cisplatin Receives: Drug: IP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: month
Secondary outcomes (3)
Objective response rate
Measured: percent
Progression free survival
Measured: month
Safety profile
Measured: percent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2011
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center for Solid Tumor, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeong-Seok Lim, Clinical Research Center for Solid Tumor, Korea
- Investigators
- Dae Seog Heo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349492
- Sponsor's protocol ID
- CRCST-L-0001
- Status last verified
- Mar 2012
- First submitted
- 5 Jul 2006
- Last updated
- 4 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Phase III Trial Comparing Etoposide/Cisplatin (EP) With Irinotecan/Cisplatin (IP) in Patients With Previously Untreated, Extensive Disease (ED) Small Cell Lung Cancer (SCLC)
- ClinicalTrials.gov ID
- NCT00349492
- Acronym / sponsor ID
- CRCST-L-0001
- Conditions
- Small Cell Lung Cancer
- Keywords
- Small Cell Lung Cancer, Extensive Disease, Chemotherapy, Randomisation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Clinical Research Center for Solid Tumor, KoreaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Jul 2006 (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.
This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms.
Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks
Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1.5 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EP | Active comparator | Drug: IPetoposide + cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically diagnosed small cell lung cancer
- Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion)
- If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)
- No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy)
- One or more measurable disease by RECIST criteria
Key exclusion criteria (4 listed)
- History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years
- Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
- Uncontrolled serious infection
- Enrollment in other study within 30 days
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 |
|---|---|---|
| IPAlso: irinotecan + cisplatinirinotecan+cisplatin | Drug | EP |
Primary outcome
Overall survival
Time frame: month
3 secondary outcomes
Objective response rate
Time frame: percent
Progression free survival
Time frame: month
Safety profile
Time frame: percent
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 4 Dec 2013.
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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.
Dae Seog Heo, MD, PhD principal investigator
Seoul National University Hospital
14 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 IP in people with Small Cell Lung Cancer, run by Clinical Research Center for Solid Tumor, Korea at 14 sites in South Korea.
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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. 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: month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2013.