Extensive DiseasePhase 3NCT00812266
Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)
A Phase 3 study testing topotecan + cisplatin and Etoposide + carboplatin in people with Extensive Disease and First-Line, run by Danish Oncological Lung Cancer Group at 1 site in Denmark.
Trial summary
Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive Disease, First-Line, Small Cell Lung Cancer
- What is being tested?
- topotecan + cisplatin and Etoposide + carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Jan 2015
- 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 confirmed SCLC
- Extensive stage
- No prior chemotherapy
- WHO PS 0-3
- Adequate organ function (liver, kidney)
- Adequate hematology (bone marrow)
- Informed consent
Who cannot join
- PS 4
- Inadequate organ function
- Uncontrolled infection
- Concomitant major medical contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease
Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.
Read the detailed description
Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3
- Conditions
- Extensive Disease, First-Line, Small Cell Lung Cancer
- Being tested
- topotecan + cisplatin, Etoposide + carboplatin
- Keywords
- SCLC, Extensive disease, topotecan
- 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.
topotecan + cisplatinDrug
topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W
Etoposide + carboplatinDrug
Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Topotecan + cisplatin Receives: Drug: topotecan + cisplatin |
| B | Active comparator | Etoposide + carboplatin Receives: Drug: Etoposide + carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 years survival
Measured: 2 years
Secondary outcomes (1)
Response rates
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2013
- Study completionJan 2015
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive DiseaseStudies 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
- Danish Oncological Lung Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seppo W. Langer, Danish Oncological Lung Cancer Group
- Investigators
- Seppo W Langer, MD PhD, Principal investigator, Dept. of Oncology, Rigshospitalet, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812266
- Sponsor's protocol ID
- DOLG7
- Other IDs
- DOLG7
- Status last verified
- Jan 2016
- First submitted
- 19 Dec 2008
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease
- ClinicalTrials.gov ID
- NCT00812266
- Acronym / sponsor ID
- DOLG7
- Conditions
- Extensive Disease, First-Line, Small Cell Lung Cancer
- Keywords
- SCLC, Extensive disease, topotecan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Danish Oncological Lung Cancer GroupUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 22 Dec 2008 (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.
Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.
Detailed description
Fase III, multicenter randomised trial comparing up to six cycles of carboplatin and etoposide with up to six cycles of topotecan and cisplatin in patients with extensive stage small cell lung cancer and PS 0-3
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: topotecan + cisplatinTopotecan + cisplatin |
| B | Active comparator | Drug: Etoposide + carboplatinEtoposide + carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed SCLC
- Extensive stage
- No prior chemotherapy
- WHO PS 0-3
- Adequate organ function (liver, kidney)
Key exclusion criteria (4 listed)
- PS 4
- Inadequate organ function
- Uncontrolled infection
- Concomitant major medical contraindications
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 |
|---|---|---|
| topotecan + cisplatintopotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W | Drug | A |
| Etoposide + carboplatinEtoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W | Drug | B |
Primary outcome
2 years survival
Time frame: 2 years
1 secondary outcome
Response rates
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
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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.
Seppo W Langer, MD PhD principal investigator
Dept. of Oncology, Rigshospitalet, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topotecan + cisplatin and Etoposide + carboplatin in people with Extensive Disease and First-Line, run by Danish Oncological Lung Cancer Group at 1 site in Denmark.
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 7 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: stopped early, as of the sponsor's last update on 26 Jan 2016. 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 Denmark. 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 (reason given: Slow accrual). 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?
2 years survival (time frame: 2 years). 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 26 Jan 2016.