Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

Intergroupe Francophone de Cancerologie Thoracique

Status and phase: Completed; Phase 2

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

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00198380

IFCT-0401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Gefitinib