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Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 20, 2005
Last Update Posted: April 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Intergroupe Francophone de Cancerologie Thoracique
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.

Condition Intervention Phase
Pneumonic-type Adenocarcinoma (P-ADC) Lung Adenocarcinoma With Bronchiolo-alveolar Feature Drug: Gefitinib Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)

Resource links provided by NLM:

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Disease control rate after 3 months of treatment [ Time Frame: Month ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 3-month ]
  • Time to progression [ Time Frame: month ]
  • Survival [ Time Frame: month ]
  • Prediction disease control by clinical and biological markers [ Time Frame: month ]

Enrollment: 90
Study Start Date: April 2005
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Gefitinib
Gefitinib 250 mg/day, until progression or severe toxicity

Detailed Description:
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198380

CHU Besancon - Pneumologie
Besancon, France, 25000
APHP - CHU Avicenne - Oncologie Medicale
Bobigny, France, 93000
Centre F. Baclesse
Caen, France, 14000
CHU - Pneumologie
Caen, France, 14000
CHU Grenoble - pneumologie
Grenoble, France, 38000
HCL - Croix-Rousse
Lyon, France, 69000
APHP - Saint-Antoine - pneumologie
Paris, France, 75012
Hopital Tenon - Pneumologie
Paris, France, 75020
HCL - Lyon Sud (Pneumologie)
Pierre Bénite, France, 69495
CHU Saint-Etienne Pneumologie
Saint-Etienne, France, 42000
CHU Lyautey - Pneumologie
Strasbourg, France, 63000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Principal Investigator: Jacques Cadranel, Pr IFCT
  More Information

Additional Information:
Responsible Party: Pr Jacques Cadranel, Intergroupe Francophone de Cancérologie Thoracique
ClinicalTrials.gov Identifier: NCT00198380     History of Changes
Other Study ID Numbers: IFCT-0401
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: April 30, 2010
Last Verified: April 2010

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Adenocarcinoma, Bronchiolo-Alveolar

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action