Last updated: 11/03/2018 13:37:53
SCOT Registry: Small Cell Lung Cancer Treatment and OutcomeSCOT
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: SCOT Registry: Small Cell Lung Cancer Treatment and Outcome
Trial description: The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC.Data will be entered into an electronic CRF (eCRF) via Internet access.Treatment plan remains the responsibility of the patient’s physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC.Approximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Registry with disease, treatment and outcome data collected.
Timeframe: 6-9mth recruitment period, 18mth study duration.
Secondary outcomes:
survival rates
Timeframe: 18 month period
Interventions:
Drug: HYCAMTIN
Enrollment:
500
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Small Cell
Product
topotecan
Collaborators
Not applicable
Study date(s)
November 2009 to February 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Male or Female >/= 18 years
- Diagnosis of small cell lung cancer
- Concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
- Patient presenting with recurrence of SCLC.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or Female >/= 18 years
- Diagnosis of small cell lung cancer
- Patient newly diagnosed with SCLC
- Has given written informed consent (if applicable)
Exclusion criteria:
- Concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
- Patient presenting with recurrence of SCLC.
- Patients who has received any chemotherapy for the SCLC.
Trial location(s)
Location
GSK Investigational Site
Seongnam-si, Gyeonggi-do, South Korea, 463-707
Status
Study Complete
Location
GSK Investigational Site
Velbert, Nordrhein-Westfalen, Germany, 42551
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51109
Status
Study Complete
Location
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53113
Status
Study Complete
Location
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
Status
Study Complete
Location
GSK Investigational Site
Suwon, Gyeonggi-do, South Korea, 442-723
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-29-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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