Small Cell Lung CancerPhase 2/3NCT00168896
A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
A Phase 2/3 study testing Carboplatin plus Irinotecan vs Carboplatin plus Etoposide in people with Small Cell Lung Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Comparison of two combination chemotherapies in the treatment of patients with SLCL Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Carboplatin plus Irinotecan vs Carboplatin plus Etoposide
- How many people
- 286 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2001to Dec 2006
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cytological or histological proven SCLC Stage I or II at 1st diagnosis
- no prior chemotherapy
- measurable tumor disease
- karnofsky performance 70
Who cannot join
- second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
- NYHA III
- chronic diarrhea, obstructive bowel syndrome
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hematology & Oncology Charité CBF Berlin, Germany
Berlin, State of Berlin, 12203
Ulrich Keilholz, MD, +49-30-8445-3596, ulrich.keilholz@charite.de
Alexander Schmittel, MD, +49-30-8445-3090, alexander.schmittel@charite.de
About this study
Official title: A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage
Comparison of two combination chemotherapies in the treatment of patients with SLCL
Read the detailed description
Comparison of two combination chemotherapies in the treatment of patients with SLCL
The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Carboplatin plus Irinotecan vs Carboplatin plus Etoposide
- Keywords
- SCLC
- 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.
Carboplatin plus Irinotecan vs Carboplatin plus EtoposideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint:
Documentation of the remission rate ( Phase II)
Determination of progress free time (Phase III)
Secondary outcomes (5)
Secondary Endpoint:
Documentation of progress free time (Phase II)
Documentation of objective remission rate ( Phase III)
Documentation of 1-year survival rate
Documentation of safety of the drug combination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2001
- Study completionDec 2006
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.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Aventis Pharmaceuticals
- Investigators
- Ulrich Keilholz, MD, Principal investigator, Charité Campus Benjamin Franklin University Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168896
- Sponsor's protocol ID
- Haema CBF SCLC UK/AS 01
- Status last verified
- Sep 2001
- First submitted
- 9 Sep 2005
- Last updated
- 14 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage
- ClinicalTrials.gov ID
- NCT00168896
- Acronym / sponsor ID
- Haema CBF SCLC UK/AS 01
- Conditions
- Small Cell Lung Cancer
- Keywords
- SCLC
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 286 participants
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Pfizer, Aventis Pharmaceuticals
- Study start
- Oct 2001
- Study completion
- Dec 2006
- First posted
- 15 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.
Comparison of two combination chemotherapies in the treatment of patients with SLCL
Detailed description
Comparison of two combination chemotherapies in the treatment of patients with SLCL
The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cytological or histological proven SCLC Stage I or II at 1st diagnosis
- no prior chemotherapy
- measurable tumor disease
- karnofsky performance 70
Key exclusion criteria (3 listed)
- second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
- NYHA III
- chronic diarrhea, obstructive bowel syndrome
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 |
|---|---|---|
| Carboplatin plus Irinotecan vs Carboplatin plus Etoposide | Drug | – |
Primary outcome
Primary Endpoint:
Documentation of the remission rate ( Phase II)
Determination of progress free time (Phase III)
5 secondary outcomes
Secondary Endpoint:
Documentation of progress free time (Phase II)
Documentation of objective remission rate ( Phase III)
Documentation of 1-year survival rate
Documentation of safety of the drug combination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2006.
Related trials for Small Cell Lung Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
Not yet recruitingPhase 1
A Phase 1 Trial of KAN-001 With Pembrolizumab, With or Without Chemotherapy, in Participants With PD-L1-Positive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
RecruitingPhase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Advanced Lung Non-Small Cell Carcinoma, Recurrent 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.
Ulrich Keilholz, MD principal investigator
Charité Campus Benjamin Franklin University Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Carboplatin plus Irinotecan vs Carboplatin plus Etoposide in people with Small Cell Lung Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Keilholz, MD (+49-30-8445-3596, ulrich.keilholz@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint:. The study lists 3 primary outcomes in all. 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 14 Feb 2006.