Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)
NCT ID: NCT00418743
Last Updated: 2010-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
138 participants
OBSERVATIONAL
2005-12-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patients who, after (at least) a first line of chemotherapy based on platinum, had a partial response and then progressed, or who had a complete response and then relapsed within three months following the last course of this first-line therapy.
* Measurable or assessable disease.
* Life expectancy \>2 months.
* Patients with a therapeutic risk level of \<5 points (see section 6: "Treatment flowchart").
* Age \>18 years;
* Performance status (WHO) \<2;
* One measurable target lesion in a non irradiated region;
* Prior radiotherapy authorized unless it targeted the only measurable lesion;
* Biological criteria: WBC \>2000/mm3, PMN \>1500/mm3, platelets \>100 000/mm3, creatinemia \<2 x ULN, bilirubinemia \<ULN, ALT and AST \<2.5 x ULN (\< 5 N if liver metastases)
* normal ECG
* written informed consent.
Exclusion Criteria
* No objective response to platinum-based therapy
* Complete response lasting more than three months after the last course of first-line treatment.
* Symptomatic brain metastases.
* Bone metastases, carcinomatous lymphangitis, ascites or pleurisy as sole assessable disease manifestations.- Concurrent participation in another clinical trial.
* Therapeutic risk level of 6 points or more (see table)
* Uncontrolled clotting disorders;
* Uncontrolled severe infection;
* History of another malignancy, except for cervical carcinoma in situ or basocellular cancer that are considered cured;
* Psychological, familial, sociological or geographic circumstances preventing treatment follow-up as defined in the protocol;
* Patients deprived of their rights for administrative or legal reasons.
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Amgen
INDUSTRY
Groupe Francais De Pneumo-Cancerologie
OTHER
Responsible Party
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GFPC
Principal Investigators
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Christos CHOUAID, Professor
Role: PRINCIPAL_INVESTIGATOR
Groupe Francais De Pneumo-Cancerologie
Locations
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Centre Hospitalier Universitaire
Angers, , France
Site 05
Bastia, , France
Site 22
Beauvais, , France
Centre Hospitalier du Morvan
Brest, , France
Centre François Baclesse
Caen, , France
Site 43
Caen, , France
Centre Hospitalier René Dubos
Cergy-Pontoise, , France
Site 33
Créteil, , France
Site 07
Draguignan, , France
Site 32
Elbeuf, , France
Site 04
Gap, , France
Centre Hospitalier Les Oudairies
La Roche-sur-Yon, , France
Hospital du Cluzeau
Limoges, , France
Centre Hospitalier Régional
Longjumeau, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Site 25
Mantes-la-Jolie, , France
Site 06
Marseille, , France
Site 27
Martigues, , France
Site 01
Meaux, , France
Hospital Saint Antoine
Paris, , France
Site 17
Rouen, , France
Hôpital Yves Le Foll
Saint-Brieuc, , France
Site 14
Toulon, , France
Site 11
Villefranche-sur-Saône, , France
Countries
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Central Contacts
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Facility Contacts
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Eric BOUCHAERT, Doctor
Role: primary
Radj GERVAIS, Professor
Role: primary
Isabelle MONNET, Doctor
Role: primary
Philippe DAVID
Role: primary
Jean B AULIAC, Doctor
Role: primary
Hervé JULLIAN, Doctor
Role: primary
Dominique PAILLOTIN, DOCTOR
Role: primary
Henri BERARD, Doctor
Role: primary
Lionel FALCHERO, Doctor
Role: primary
Related Links
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Groupement Francais de Pneumo-cancérologie
Other Identifiers
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GFPC 05-01
Identifier Type: -
Identifier Source: org_study_id
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