Non-small Cell Lung CancerPhase 2NCT00198367
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Cisplatin-Gemzar, Cisplatin-Navelbine-Radiotherapy and Carboplatin-Taxol-Radiotherapy in people with Non-small Cell Lung Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Cisplatin-Gemzar, Cisplatin-Navelbine-Radiotherapy and Carboplatin-Taxol-Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2003to Jul 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operable and resectable stage IIIA (T1-3, N2) NSCLC
- World Health Organization (WHO) performance status of 1 or less
Who cannot join
- Severe cardiac, respiratory, renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Lyon-Sud - Radiotherapie/Oncologie
Pierre-Bénite
About this study
Official title: Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.
Read the detailed description
These results justify the choice of the study design currently suggested, testing the preoperative feasibility
- chemotherapy: cisplatin-Gemzar (arm A) or
- chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C).
The results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III study.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Cisplatin-Gemzar, Cisplatin-Navelbine-Radiotherapy, Carboplatin-Taxol-Radiotherapy
- Keywords
- operable and resectable stage IIIA (T1-3, N2) NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin-GemzarDrug
Cisplatin-Navelbine-RadiotherapyDrug
Carboplatin-Taxol-RadiotherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin-Gemzar | Experimental | Cisplatin-Gemzar Receives: Drug: Cisplatin-Gemzar |
| Cisplatin-Navelbine-Radiotherapy | Experimental | Cisplatin-Navelbine-Radiotherapy Receives: Drug: Cisplatin-Navelbine-Radiotherapy |
| Carboplatin-Taxol-Radiotherapy | Experimental | Carboplatin-Taxol-Radiotherapy Receives: Drug: Carboplatin-Taxol-Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
Measured: at week 22
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 startJan 2003
- Primary completionJan 2008
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francoise Mornex, Pr, Principal investigator, Hospices Civils de LyonBernard Milleron, Dr, Principal investigator, Intergroupe Francophone de Cancerologie Thoracique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198367
- Sponsor's protocol ID
- IFCT-0101
- Status last verified
- May 2016
- First submitted
- 13 Sep 2005
- Last updated
- 28 May 2019
- Results posted
- No
Publications
Girard N, Mornex F, Douillard JY, Bossard N, Quoix E, Beckendorf V, Grunenwald D, Amour E, Milleron B. Is neoadjuvant chemoradiotherapy a feasible strategy for stage IIIA-N2 non-small cell lung cancer? Mature results of the randomized IFCT-0101 phase II trial. Lung Cancer. 2010 Jul;69(1):86-93. doi: 10.1016/j.lungcan.2009.10.003. Epub 2009 Oct 29.
PubMed 19879013
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT00198367
- Acronym / sponsor ID
- IFCT-0101
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- operable and resectable stage IIIA (T1-3, N2) NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jul 2012 (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.
Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.
Detailed description
These results justify the choice of the study design currently suggested, testing the preoperative feasibility
- chemotherapy: cisplatin-Gemzar (arm A) or
- chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C).
The results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cisplatin-Gemzar | Experimental | Drug: Cisplatin-GemzarCisplatin-Gemzar |
| Cisplatin-Navelbine-Radiotherapy | Experimental | Drug: Cisplatin-Navelbine-RadiotherapyCisplatin-Navelbine-Radiotherapy |
| Carboplatin-Taxol-Radiotherapy | Experimental | Drug: Carboplatin-Taxol-RadiotherapyCarboplatin-Taxol-Radiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Operable and resectable stage IIIA (T1-3, N2) NSCLC
- World Health Organization (WHO) performance status of 1 or less
Key exclusion criteria (1 listed)
- Severe cardiac, respiratory, renal or hepatic failure
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 |
|---|---|---|
| Cisplatin-Gemzar | Drug | Cisplatin-Gemzar |
| Cisplatin-Navelbine-Radiotherapy | Drug | Cisplatin-Navelbine-Radiotherapy |
| Carboplatin-Taxol-Radiotherapy | Drug | Carboplatin-Taxol-Radiotherapy |
Primary outcome
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities)
Time frame: at week 22
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 28 May 2019.
- Results publication: PubMed 19879013Girard N, Mornex F, Douillard JY, Bossard N, Quoix E, Beckendorf V, Grunenwald D, Amour E, Milleron B. Is neoadjuvant chemoradiotherapy a feasible strategy for stage IIIA-N2 non-small cell lung cancer? Mature results of the randomized IFCT-0101 phase II trial. Lung Cancer. 2010 Jul;69(1):86-93. doi: 10.1016/j.lungcan.2009.10.003. Epub 2009 Oct 29.
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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.
Francoise Mornex, Pr principal investigator
Hospices Civils de Lyon
Bernard Milleron, Dr principal investigator
Intergroupe Francophone de Cancerologie Thoracique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin-Gemzar, Cisplatin-Navelbine-Radiotherapy and Carboplatin-Taxol-Radiotherapy in people with Non-small Cell Lung Cancer, run by Hospices Civils de Lyon at 1 site 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 2 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 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
percentage of patients alive and operated on without grade 4 toxicity (except for hematological and N/V toxicities) (time frame: at week 22). 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 NCT00198367, which also lists 1 linked publication.
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 28 May 2019.