SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

NCT00997061 | Completed

• 1 other identifier: 112791
• Study Type: observational
• Target: 500
• Locations: 13 countries
• Sites: 60

Brief Summary

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.

Conditions

Lung Cancer, Small Cell

Outcome Measures

Primary Outcomes (1)

• Registry with disease, treatment and outcome data collected.

  6-9mth recruitment period, 18mth study duration.

Secondary Outcomes (1)

• survival rates

  18 month period

Study Arms (1)

HYCAMTIN

Drug: HYCAMTIN

Interventions

HYCAMTIN DRUG

Observing patients on HYCAMTIN and other drugs for SCLC.

HYCAMTIN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Newly Diagnosed SCLC patients

You may qualify if:

• Male or Female \>/= 18 years
• Diagnosis of small cell lung cancer
• Patient newly diagnosed with SCLC
• Has given written informed consent (if applicable)

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (61)

GSK Investigational Site

Graz, A-8036, Austria

Location

GSK Investigational Site

Innsbruck, A-6020, Austria

Location

GSK Investigational Site

Salzburg, 5020, Austria

Location

GSK Investigational Site

Vienna, 1130, Austria

Location

GSK Investigational Site

Brno, 625 00, Czechia

Location

GSK Investigational Site

Pilsen, 305 99, Czechia

Location

GSK Investigational Site

Tallinn, 11619, Estonia

Location

GSK Investigational Site

Besançon, 25030, France

Location

GSK Investigational Site

Caen, 14033, France

Location

GSK Investigational Site

Créteil, 94010, France

Location

GSK Investigational Site

Draguignan, 83300, France

Location

GSK Investigational Site

Lorient, 56322, France

Location

GSK Investigational Site

Paris, 75020, France

Location

GSK Investigational Site

Perpignan, 66000, France

Location

GSK Investigational Site

Pessac, 33604, France

Location

GSK Investigational Site

Pierre-Bénite, 69495, France

Location

GSK Investigational Site

Saint-Priest-en-Jarez, 42271, France

Location

GSK Investigational Site

Strasbourg, 67091, France

Location

GSK Investigational Site

Munich, Bavaria, 81925, Germany

Location

GSK Investigational Site

Immenhausen, Hesse, 34376, Germany

Location

GSK Investigational Site

Kassel, Hesse, 34125, Germany

Location

GSK Investigational Site

Wiesbaden, Hesse, 65199, Germany

Location

GSK Investigational Site

Leer, Lower Saxony, 26789, Germany

Location

GSK Investigational Site

Bonn, North Rhine-Westphalia, 53113, Germany

Location

GSK Investigational Site

Cologne, North Rhine-Westphalia, 51109, Germany

Location

GSK Investigational Site

Hemer, North Rhine-Westphalia, 58675, Germany

Location

GSK Investigational Site

Velbert, North Rhine-Westphalia, 42551, Germany

Location

GSK Investigational Site

Athens, 115 27, Greece

Location

GSK Investigational Site

Heraklion, Crete, 71110, Greece

Location

GSK Investigational Site

Thessaloniki, 57010, Greece

Location

GSK Investigational Site

Mátraháza, 3233, Hungary

Location

GSK Investigational Site

Székesfehérvár, 8000, Hungary

Location

GSK Investigational Site

Lecce, Apulia, 73100, Italy

Location

GSK Investigational Site

Parma, Emilia-Romagna, 43100, Italy

Location

GSK Investigational Site

Rozzano (MI), Lombardy, 20089, Italy

Location

GSK Investigational Site

Orbassano (TO), Piedmont, 10043, Italy

Location

GSK Investigational Site

Sassari, Sardinia, 07100, Italy

Location

GSK Investigational Site

Kaunas, LT-50009, Lithuania

Location

GSK Investigational Site

Klaipėda, LT-92228, Lithuania

Location

GSK Investigational Site

Vilnius, LT-08660, Lithuania

Location

GSK Investigational Site

Vilnius, LT-08661, Lithuania

Location

GSK Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

GSK Investigational Site

Breda, 4818 CK, Netherlands

Location

GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

Location

GSK Investigational Site

Groningen, 9713 GZ, Netherlands

Location

GSK Investigational Site

Gorzów Wielkopolski, 66-400, Poland

Location

GSK Investigational Site

Głuchołazy, 41-340, Poland

Location

GSK Investigational Site

Krakow, 31-115, Poland

Location

GSK Investigational Site

Lodz, 93-509, Poland

Location

GSK Investigational Site

Lublin, 20-954, Poland

Location

GSK Investigational Site

Warsaw, 00-909, Poland

Location

GSK Investigational Site

Golnik, 4204, Slovenia

Location

GSK Investigational Site

Ljubljana, 1000, Slovenia

Location

GSK Investigational Site

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

GSK Investigational Site

Suwon, Gyeonggi-do, 442-723, South Korea

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Palma de Mallorca, 07014, Spain

Location

GSK Investigational Site

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

IT (5); GR (3); CZ (2); FR (11); HU (2); NL (4); SL (2); DE (9); AU (4); ES (5); LI (4); KR (3); PL (6)