Clinical trial NCT00418743: Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Small Cell Lung Cancer
Keywords: cancer
Lung cancer
small-cell lung cancer
Lead sponsor: Groupe Francais De Pneumo-Cancerologie
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Amgen
First posted: 2007-01-05
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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;
* 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:

* 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)
* 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Bastia
country: France
facility: Site 05
city: Beauvais
country: France
facility: Site 22
city: Brest
country: France
facility: Centre Hospitalier du Morvan
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: Site 43
city: Cergy-pontoise
country: France
facility: Centre Hospitalier René Dubos
city: Creteil
country: France
facility: Site 33
city: Draguignan
country: France
facility: Site 07
city: Elbeuf
country: France
facility: Site 32
city: GAP
country: France
facility: Site 04
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Les Oudairies
city: Limoges
country: France
facility: Hospital du Cluzeau
city: Longjumeau
country: France
facility: Centre Hospitalier Régional
city: Lyon
country: France
facility: Centre Hospitalier Lyon Sud
city: Mantes La Jolie
country: France
facility: Site 25
city: Marseille
country: France
facility: Site 06
city: Martigues
country: France
facility: Site 27
city: Meaux
country: France
facility: Site 01
city: Paris
country: France
facility: Hospital Saint Antoine
city: Rouen
country: France
facility: Site 17
city: Saint Brieuc
country: France
facility: Hôpital Yves Le Foll
city: Toulon
country: France
facility: Site 14
city: Villefranche Sur Saone
country: France
facility: Site 11
Study officials:
affiliation: Groupe Francais De Pneumo-Cancerologie
name: Christos CHOUAID, Professor
role: PRINCIPAL_INVESTIGATOR
References: