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Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
Intergroupe Francophone de Cancerologie Thoracique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonic-type Adenocarcinoma (P-ADC) focused on measuring Adenocarcinoma, Bronchiolo-Alveolar

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Besancon - Pneumologie
  • APHP - CHU Avicenne - Oncologie Medicale
  • Centre F. Baclesse
  • CHU - Pneumologie
  • CHU Grenoble - pneumologie
  • HCL - Croix-Rousse
  • APHP - Saint-Antoine - pneumologie
  • Hopital Tenon - Pneumologie
  • HCL - Lyon Sud (Pneumologie)
  • CHU Saint-Etienne Pneumologie
  • CHU Lyautey - Pneumologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Disease control rate after 3 months of treatment

Secondary Outcome Measures

Quality of life
Time to progression
Survival
Prediction disease control by clinical and biological markers

Full Information

First Posted
September 13, 2005
Last Updated
April 28, 2010
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00198380
Brief Title
Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature
Official Title
Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonic-type Adenocarcinoma (P-ADC), Lung Adenocarcinoma With Bronchiolo-alveolar Feature
Keywords
Adenocarcinoma, Bronchiolo-Alveolar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Intervention Description
Gefitinib 250 mg/day, until progression or severe toxicity
Primary Outcome Measure Information:
Title
Disease control rate after 3 months of treatment
Time Frame
Month
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
3-month
Title
Time to progression
Time Frame
month
Title
Survival
Time Frame
month
Title
Prediction disease control by clinical and biological markers
Time Frame
month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Cadranel, Pr
Organizational Affiliation
Intergroupe Francophone de Cancerologie Thoracique
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besancon - Pneumologie
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
APHP - CHU Avicenne - Oncologie Medicale
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Centre F. Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU - Pneumologie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Grenoble - pneumologie
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
HCL - Croix-Rousse
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
APHP - Saint-Antoine - pneumologie
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital Tenon - Pneumologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
HCL - Lyon Sud (Pneumologie)
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Saint-Etienne Pneumologie
City
Saint-Etienne
ZIP/Postal Code
42000
Country
France
Facility Name
CHU Lyautey - Pneumologie
City
Strasbourg
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18235410
Citation
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.
Results Reference
background
PubMed Identifier
12796162
Citation
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.
Results Reference
background
PubMed Identifier
17409882
Citation
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. Erratum In: J Thorac Oncol. 2006 Jun;1(5):405.
Results Reference
background
PubMed Identifier
19574932
Citation
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.
Results Reference
result
PubMed Identifier
19581016
Citation
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.
Results Reference
result
Links:
URL
http://www.ifct.fr
Description
Official website

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Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

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