Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma

NCT ID: NCT00384826

Last Updated: 2015-02-16

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2014-02-28

Brief Summary

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To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.

Detailed Description

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Conditions

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Adenocarcinoma, Bronchiolo-Alveolar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

erlotinib

Intervention Type DRUG

Erlotinib 150 mg/day (until progression)

2

Group Type EXPERIMENTAL

paclitaxel + carboplatine

Intervention Type DRUG

Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)

Interventions

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erlotinib

Erlotinib 150 mg/day (until progression)

Intervention Type DRUG

paclitaxel + carboplatine

Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* CBA histologically proven (or cytologically with pneumonic presentation) PS \< 3 signed and written informed consent

Exclusion Criteria

* visible tumoral lesion in bronchial fibroscopy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intergroupe Francophone de Cancerologie Thoracique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Cadranel

Role: PRINCIPAL_INVESTIGATOR

APHP Hopital Tenon (Pneumologie) - Paris - France

Locations

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Centre Hospitalier - Pneumologie

Belfort, , France

Site Status

APHP - CHU Avicenne - Oncologie Medicale

Bobigny, , France

Site Status

Centre F. Baclesse

Caen, , France

Site Status

CHU - Pneumologie

Caen, , France

Site Status

CHU Grenoble - pneumologie

Grenoble, , France

Site Status

APHP - Saint-Antoine - pneumologie

Paris, , France

Site Status

APHP - Hopital Tenon - Pneumologie

Paris, , France

Site Status

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

Site Status

CHU Lyautey - Pneumologie

Strasbourg, , France

Site Status

Countries

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France

References

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Wislez M, Gounant V, Cadranel J. [Bronchioloalveolar carcinoma]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S70-5. French.

Reference Type BACKGROUND
PMID: 16340839 (View on PubMed)

Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77. doi: 10.1378/chest.123.6.1868.

Reference Type BACKGROUND
PMID: 12796162 (View on PubMed)

Cadranel J, Gervais R, Merle P, Moro-Sibilot D, Westeel V, Bigay-Game L, Quoix E, Friard S, Barlesi F, Lethrosne C, Moreau L, Monnet I, Salaun M, Oliviero G, Souquet PJ, Antoine M, Langlais A, Morin F, Wislez M, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504. Eur Respir J. 2015 Nov;46(5):1440-50. doi: 10.1183/13993003.02358-2014. Epub 2015 Sep 17.

Reference Type DERIVED
PMID: 26381515 (View on PubMed)

Related Links

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http://www.ifct.fr

Official French Intergroup website

Other Identifiers

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IFCT-0504

Identifier Type: -

Identifier Source: org_study_id

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