Small Cell Lung CancerNCT00418743
Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)
An observational study of Small Cell Lung Cancer, run by Groupe Francais De Pneumo-Cancerologie at 24 sites in France.
Trial summary
The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- How many people
- 138 participants
- Where
- 24 sitesFrance
- Study dates
- Dec 2005to May 2010
- Phase
- Observational
- 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
Study population: Patients with Small-cell lung cancer 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.
Who may be able to join
- Small-cell lung cancer.
- 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;
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- 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.
Who cannot join
- Non small-cell lung cancer.
- 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)
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- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites, 24 recruiting
- Recruiting
Centre Hospitalier Universitaire
Angers, 49033
Thierry URBAN, Doctor, +33241355844, thurban@chu-angers.fr
Thierry URBAN, Doctor
- Recruiting
Site 05
Bastia, 20200
Jean Cl MOURIES, Doctor, +33495591080, jcmouries@ch-bastia.fr
Jean Cl MOURIES, Doctor
- Recruiting
Site 22
Beauvais, 60021
Eric BOUCHAERT, Doctor
Eric BOUCHAERT, Doctor
- Recruiting
Centre Hospitalier du Morvan
Brest, 29200
Gilles ROBINET, Doctor, +33298223428, gilles.robinet@chu-brest.fr
Gilles ROBINET, Doctor
- Recruiting
Centre François Baclesse
Caen, 14000
Radj GERVAIS, Doctor, +33231455013, r.gervais@baclesse.fr
Radj GERVAIS, Doctor
- Recruiting
Site 43
Caen, 14000
Radj GERVAIS, Professor
Radj GERVAIS, Professor
- Recruiting
Centre Hospitalier René Dubos
Cergy-Pontoise, 95301
Gislaine FRABOULET, Doctor, +33130754282, gislaine.fraboulet@ch-pontoise.fr
Gislaine FRABOULET, Doctor
- Recruiting
Site 33
Créteil, 94010
Isabelle MONNET, Doctor
Isabelle MONNET, Doctor
- Recruiting
Site 07
Draguignan, 83300
Hervé LECAER, Doctor, +33 4 94 60 51 12, herve.lecaer@ch-draguignan.fr
Hervé LE CAER, Doctor
- Recruiting
Site 32
Elbeuf, 76503
Philippe DAVID
Philippe DAVID, Professor
- Recruiting
Site 04
Gap, 05000
Pascal THOMAS, Doctor, +33 4 92 40 61 26, pascal.thomas@chicas-gap.fr
Pascal THOMAS, Doctor
- Recruiting
Centre Hospitalier Les Oudairies
La Roche-sur-Yon, 85000
Acya BIZIEUX-TAMINY, Doctor, +33251446164, acya.bizieux@chd-vendee.fr
Acya BIZIEUX-TAMINY, Doctor
- Recruiting
Hospital du Cluzeau
Limoges, 87042
Alain VERGNENEGRE, Professor, +33 5 55 05 66 29, avergne@unilim.fr
Alain VERGNENEGRE, Professor
- Recruiting
Centre Hospitalier Régional
Longjumeau, 91160
Gérard OLIVIERO, Doctor, +33164543181, gerard.oliviero@ch-longjumeau.fr
Gérard OLIVIERO, Doctor
- Recruiting
Centre Hospitalier Lyon Sud
Lyon, 69495
Laurence GERINIERE, Doctor, +33478861328, lairence.geriniere@chu-lyon.fr
Laurence GERINIERE, Doctor
- Recruiting
Site 25
Mantes-la-Jolie, 78200
Jean B AULIAC, Doctor
Jean Be AULIAC, Doctor
- Recruiting
Site 06
Marseille, 13274
Fabrice BARLESI, Doctor, +33 4 91 74 47 36, fabrice.barlesi@aphm.fr
Fabrice BARLESI, Professor
- Recruiting
Site 27
Martigues, 13695
Hervé JULLIAN, Doctor
Hervé JULLIAN, Doctor
- Recruiting
Site 01
Meaux, 77108
Francois BLANCHON, Doctor, +33 1 64 35 38 56, f-blanchon@ch-meaux.fr
Francois BLANCHON, Doctor
- Recruiting
Hospital Saint Antoine
Paris, 75012
Christos CHOUAID, Professor, +33 1 48 28 25 16, christos.chouaid@sat.ap-hop-paris.fr
Christos CHOUAID, Professor
- Recruiting
Site 17
Rouen, 76233
Dominique PAILLOTIN, DOCTOR
Dominique PAILLOTIN, Doctor
- Recruiting
Hôpital Yves Le Foll
Saint-Brieuc, 22023
Gwenaelle LE GARFF, Doctor, +33296017123, gwenaelle.legarff@ch-stbrieuc.fr
Gwenaelle LE GARFF, Doctor
- Recruiting
Site 14
Toulon, 83800
Henri BERARD, Doctor
Henri BERARD, Doctor
- Recruiting
Site 11
Villefranche-sur-Saône, 69655
Lionel FALCHERO, Doctor, +33 4 74 09 27 23
Lionel FALCHERO, Doctor
About this study
Official title: A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.
The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
Read the detailed description
Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
- Conditions
- Small Cell Lung Cancer
- Keywords
- cancer, Lung cancer, small-cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma, Neoplasms, Lung Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startDec 2005
- Study completionMay 2010 (estimated)
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Francais De Pneumo-Cancerologie
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Amgen
- Investigators
- Christos CHOUAID, Professor, Principal investigator, Groupe Francais De Pneumo-Cancerologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418743
- Sponsor's protocol ID
- GFPC 05-01
- Status last verified
- Mar 2010
- First submitted
- 4 Jan 2007
- Last updated
- 9 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.
- ClinicalTrials.gov ID
- NCT00418743
- Acronym / sponsor ID
- GFPC 05-01
- Conditions
- Small Cell Lung Cancer
- Keywords
- cancer, Lung cancer, small-cell lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Groupe Francais De Pneumo-CancerologieUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Amgen
- Study start
- Dec 2005
- Study completion
- May 2010 (estimated)
- First posted
- 5 Jan 2007 (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.
The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
Detailed description
Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Small-cell lung cancer 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.
Key inclusion criteria (12 listed)
- Small-cell lung cancer.
- 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").
Key exclusion criteria (11 listed)
- Non small-cell lung cancer.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2010.
- Groupement Francais de Pneumo-cancérologieLink provided by the sponsor.
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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.
Christos CHOUAID, Professor principal investigator
Groupe Francais De Pneumo-Cancerologie
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer, run by Groupe Francais De Pneumo-Cancerologie at 24 sites in France.
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 12 inclusion and 11 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 9 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. 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.
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 Christos CHOUAID, Professor (+33 1 49 28 25 16, christos.chouid@sat.ap-hop-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Mar 2010.