Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

March 6, 2024 updated by: Intergroupe Francophone de Cancerologie Thoracique

Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • CHU Besancon - Pneumologie
      • Bobigny, France, 93000
        • APHP - CHU Avicenne - Oncologie Medicale
      • Caen, France, 14000
        • Centre F. Baclesse
      • Caen, France, 14000
        • CHU - Pneumologie
      • Grenoble, France, 38000
        • CHU Grenoble - pneumologie
      • Lyon, France, 69000
        • HCL - Croix-Rousse
      • Paris, France, 75020
        • Hopital Tenon - Pneumologie
      • Paris, France, 75012
        • APHP - Saint-Antoine - pneumologie
      • Pierre Bénite, France, 69495
        • HCL - Lyon Sud (Pneumologie)
      • Saint-Etienne, France, 42000
        • CHU Saint-Etienne Pneumologie
      • Strasbourg, France, 63000
        • CHU Lyautey - Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Gefitinib
Gefitinib 250 mg/day, until progression or severe toxicity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease control rate after 3 months of treatment
Time Frame: Month
Month

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 3-month
3-month
Time to progression
Time Frame: month
month
Survival
Time Frame: month
month
Prediction disease control by clinical and biological markers
Time Frame: month
month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Jacques Cadranel, Pr, Intergroupe Francophone de Cancerologie Thoracique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonic-type Adenocarcinoma (P-ADC)

Clinical Trials on Gefitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe