Lung Adenocarcinoma With Bronchiolo-alveolar Feature Clinical Trial
Official title:
Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)
| NCT number | NCT00198380 |
| Other study ID # | IFCT-0401 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | April 2005 |
| Est. completion date | December 2009 |
| Verified date | March 2024 |
| Source | Intergroupe Francophone de Cancerologie Thoracique |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | December 2009 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Besancon - Pneumologie | Besancon | |
| France | APHP - CHU Avicenne - Oncologie Medicale | Bobigny | |
| France | Centre F. Baclesse | Caen | |
| France | CHU - Pneumologie | Caen | |
| France | CHU Grenoble - pneumologie | Grenoble | |
| France | HCL - Croix-Rousse | Lyon | |
| France | APHP - Saint-Antoine - pneumologie | Paris | |
| France | Hopital Tenon - Pneumologie | Paris | |
| France | HCL - Lyon Sud (Pneumologie) | Pierre Bénite | |
| France | CHU Saint-Etienne Pneumologie | Saint-Etienne | |
| France | CHU Lyautey - Pneumologie | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| Intergroupe Francophone de Cancerologie Thoracique | AstraZeneca |
France,
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. — View 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 — View 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. — View 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 — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease control rate after 3 months of treatment | Month | ||
| Secondary | Quality of life | 3-month | ||
| Secondary | Time to progression | month | ||
| Secondary | Survival | month | ||
| Secondary | Prediction disease control by clinical and biological markers | month |