Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

NCT ID: NCT00198380

Last Updated: 2024-03-08

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-12-31

Brief Summary

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Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

Detailed Description

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We therefore conducted a French multicentric phase II trial (IFCT 0401) to evaluate activity and tolerance of gefitinib (250 mg/day) administered as first line treatment in patients with non-resectable P-ADC.

Conditions

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Pneumonic-type Adenocarcinoma (P-ADC) Lung Adenocarcinoma With Bronchiolo-alveolar Feature

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Gefitinib

Intervention Type DRUG

Gefitinib 250 mg/day, until progression or severe toxicity

Interventions

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Gefitinib

Gefitinib 250 mg/day, until progression or severe toxicity

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pathologically / cytologically proven ADC-P
* Non-resectable disease
* 3-month expected survival
* No prior radiotherapy or chemotherapy
* Age \>= 18 years old
* Performance status \< 4 (WHO)
* Adequate blood biological parameters

Exclusion Criteria

* Abnormal initial fibroscopy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

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, Pr

Role: PRINCIPAL_INVESTIGATOR

Intergroupe Francophone de Cancerologie Thoracique

Locations

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CHU Besancon - Pneumologie

Besançon, , 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

HCL - Croix-Rousse

Lyon, , France

Site Status

APHP - Saint-Antoine - pneumologie

Paris, , France

Site Status

Hopital Tenon - Pneumologie

Paris, , France

Site Status

HCL - Lyon Sud (Pneumologie)

Pierre-Bénite, , France

Site Status

CHU Saint-Etienne Pneumologie

Saint-Etienne, , France

Site Status

CHU Lyautey - Pneumologie

Strasbourg, , France

Site Status

Countries

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France

References

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Cadranel J, Lavole A, Gounant V, Wislez M. [Bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features: a clinico-pathological spectrum]. Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S165-70. French.

Reference Type BACKGROUND
PMID: 18235410 (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)

Garfield DH, Cadranel JL, Wislez M, Franklin WA, Hirsch FR. The bronchioloalveolar carcinoma and peripheral adenocarcinoma spectrum of diseases. J Thorac Oncol. 2006 May;1(4):344-59.

Reference Type BACKGROUND
PMID: 17409882 (View on PubMed)

Cadranel J, Quoix E, Baudrin L, Mourlanette P, Moro-Sibilot D, Morere JF, Souquet PJ, Soria JC, Morin F, Milleron B; IFCT-0401 Trial Group. IFCT-0401 Trial: a phase II study of gefitinib administered as first-line treatment in advanced adenocarcinoma with bronchioloalveolar carcinoma subtype. J Thorac Oncol. 2009 Sep;4(9):1126-35. doi: 10.1097/JTO.0b013e3181abeb5d.

Reference Type RESULT
PMID: 19574932 (View on PubMed)

Wislez M, Antoine M, Baudrin L, Poulot V, Neuville A, Pradere M, Longchampt E, Isaac-Sibille S, Lebitasy MP, Cadranel J. Non-mucinous and mucinous subtypes of adenocarcinoma with bronchioloalveolar carcinoma features differ by biomarker expression and in the response to gefitinib. Lung Cancer. 2010 May;68(2):185-91. doi: 10.1016/j.lungcan.2009.05.021. Epub 2009 Jul 5.

Reference Type RESULT
PMID: 19581016 (View on PubMed)

Related Links

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http://www.ifct.fr

Official website

Other Identifiers

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IFCT-0401

Identifier Type: -

Identifier Source: org_study_id

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