Pneumonic-type Adenocarcinoma (P-ADC)Phase 2NCT00198380
Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature
A Phase 2 study testing Gefitinib in people with Pneumonic-type Adenocarcinoma (P-ADC) and Lung Adenocarcinoma With Bronchiolo-alveolar Feature, run by Intergroupe Francophone de Cancerologie Thoracique at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonic-type Adenocarcinoma (P-ADC), Lung Adenocarcinoma With Bronchiolo-alveolar Feature
- What is being tested?
- Gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 11 sitesFrance
- Study dates
- Apr 2005to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Abnormal initial fibroscopy
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU Besancon - Pneumologie
Besançon, 25000
APHP - CHU Avicenne - Oncologie Medicale
Bobigny, 93000
Centre F. Baclesse
Caen, 14000
CHU - Pneumologie
Caen, 14000
CHU Grenoble - pneumologie
Grenoble, 38000
HCL - Croix-Rousse
Lyon, 69000
APHP - Saint-Antoine - pneumologie
Paris, 75012
Hopital Tenon - Pneumologie
Paris, 75020
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, 69495
CHU Saint-Etienne Pneumologie
Saint-Etienne, 42000
CHU Lyautey - Pneumologie
Strasbourg, 63000
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonic-type Adenocarcinoma (P-ADC), Lung Adenocarcinoma With Bronchiolo-alveolar Feature
- Being tested
- Gefitinib
- Keywords
- Adenocarcinoma, Bronchiolo-Alveolar
- Medical subject headings
- Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GefitinibDrug
Gefitinib 250 mg/day, until progression or severe toxicity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate after 3 months of treatment
Measured: Month
Secondary outcomes (4)
Quality of life
Measured: 3-month
Time to progression
Measured: month
Survival
Measured: month
Prediction disease control by clinical and biological markers
Measured: month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pneumonic-type Adenocarcinoma (P-ADC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Jacques Cadranel, Pr, Principal investigator, Intergroupe Francophone de Cancerologie Thoracique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198380
- Sponsor's protocol ID
- IFCT-0401
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2005
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18235410Wislez 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.
PubMed 12796162Garfield 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.
PubMed 17409882Cadranel 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.
PubMed 19574932Wislez 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.
PubMed 19581016
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)
- ClinicalTrials.gov ID
- NCT00198380
- Acronym / sponsor ID
- IFCT-0401
- Conditions
- Pneumonic-type Adenocarcinoma (P-ADC), Lung Adenocarcinoma With Bronchiolo-alveolar Feature
- Keywords
- Adenocarcinoma, Bronchiolo-Alveolar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Apr 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Gefitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologically / cytologically proven ADC-P
- Non-resectable disease
- 3-month expected survival
- No prior radiotherapy or chemotherapy
- Age >= 18 years old
Key exclusion criteria (1 listed)
- Abnormal initial fibroscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GefitinibGefitinib 250 mg/day, until progression or severe toxicity | Drug | 1 |
Primary outcome
Disease control rate after 3 months of treatment
Time frame: Month
4 secondary outcomes
Quality of life
Time frame: 3-month
Time to progression
Time frame: month
Survival
Time frame: month
Prediction disease control by clinical and biological markers
Time frame: month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 18235410Cadranel 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.
- Background: PubMed 12796162Wislez 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.
- Background: PubMed 17409882Garfield 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.
- Results publication: PubMed 19574932Cadranel 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 publication: PubMed 19581016Wislez 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.
- Official websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Cadranel, Pr principal investigator
Intergroupe Francophone de Cancerologie Thoracique
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib in people with Pneumonic-type Adenocarcinoma (P-ADC) and Lung Adenocarcinoma With Bronchiolo-alveolar Feature, run by Intergroupe Francophone de Cancerologie Thoracique at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate after 3 months of treatment (time frame: Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00198380, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.