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OpenTrials
Completed

NCT Number: NCT00198380

Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

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.

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Key information

Conditions

Pneumonic-type Adenocarcinoma (P-ADC) Adenocarcinoma Adenocarcinoma of Lung Adenocarcinoma, Bronchiolo-Alveolar Carcinoma Lung Adenocarcinoma With Bronchiolo-alveolar Feature Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Besancon - Pneumologie, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

Gefitinib 250 mg/day, until progression or severe toxicity

Primary outcomes

  1. Disease control rate after 3 months of treatment

    Time frame: Month

Secondary outcomes

  1. Quality of life

    Time frame: 3-month

  2. Time to progression

    Time frame: month

  3. Survival

    Time frame: month

  4. Prediction disease control by clinical and biological markers

    Time frame: month

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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