NSCLC Stage IIIBPhase 2NCT00198432
Chemoradiotherapy of NSCLC Stage IIIB
A Phase 2 study testing Paclitaxel, vinorelbine, cisplatin in people with NSCLC Stage IIIB and Concomitant Radiochemotherapy, run by Intergroupe Francophone de Cancerologie Thoracique at 1 site in France.
Trial summary
To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- NSCLC Stage IIIB, Concomitant Radiochemotherapy
- What is being tested?
- Paclitaxel, vinorelbine, cisplatin
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2002to Dec 2006
- 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
- NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural
- PS = 0 or 1
- Possibility of including all the targets in only one exposure field
- Slimming < 10% of the weight of the body
- Functions hepatic, renal and hematologic normal
- VEMS >40% and PaO2 >60 mmHg
- written and signed informed consent
Who cannot join
- NSCLC stage IV or wet-IIIB
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable
To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.
Read the detailed description
Chemotherapy:
C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²
Radiotherapy:
66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (>= 9MV)
- Conditions
- NSCLC Stage IIIB, Concomitant Radiochemotherapy
- Being tested
- Paclitaxel, vinorelbine, cisplatin
- 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.
Paclitaxel, vinorelbine, cisplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Secondary outcomes (4)
Overall survival
Time to progression
Relapse rate (local control)
Safety
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 startMar 2002
- Study completionDec 2006
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 NSCLC Stage IIIBStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pierre Fabre Laboratories, Ligue contre le cancer, France
- Investigators
- Pierre Fournel, Dr, Principal investigator, Intergroupe Francophone de Cancerologie Thoracique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198432
- Sponsor's protocol ID
- IFCT-0201
- Status last verified
- Mar 2016
- First submitted
- 13 Sep 2005
- Last updated
- 10 Mar 2016
- Results posted
- No
Publications
Fournel P, Vergnenegre A, Robinet G, Lena H, Gervais R, Le Caer H, Souquet PJ, Chavaillon JM, Bozonnat MC, Daures JP, Chouaid C, Martel-Lafay I; GFPC and IFCT Team. Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung cancer patients treated with concurrent chemoradiation: a randomised phase II trial GFPC - IFCT 02-01. Eur J Cancer. 2016 Jan;52:181-7. doi: 10.1016/j.ejca.2015.10.072. Epub 2015 Dec 12.
PubMed 26689864
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable
- ClinicalTrials.gov ID
- NCT00198432
- Acronym / sponsor ID
- IFCT-0201
- Conditions
- NSCLC Stage IIIB, Concomitant Radiochemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Pierre Fabre Laboratories, Ligue contre le cancer, France
- Study start
- Mar 2002
- Study completion
- Dec 2006
- 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.
To evaluate the best timing of the concomitant chemoradiotherapy among patients with NSCLC stage III not resectable treated by concomitant chemo-radiotherapy, either preceded by a induction chemotherapy, or followed by a consolidation chemotherapy.
Detailed description
Chemotherapy:
C = Cisplatine : 80 mg/m² P = Paclitaxel : 200 mg/m² N = Vinorelbine : 15 mg/m²
Radiotherapy:
66 Gy with 33 fractions (2 Gy/fraction, 1 fraction/day, 6,5 weeks) High energy Photons X (>= 9MV)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- NSCLC stage IIIA N2 or IIIB not resectable, except N3 sus-clavicular, nor reached pleural
- PS = 0 or 1
- Possibility of including all the targets in only one exposure field
- Slimming < 10% of the weight of the body
- Functions hepatic, renal and hematologic normal
Key exclusion criteria (1 listed)
- NSCLC stage IV or wet-IIIB
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 |
|---|---|---|
| Paclitaxel, vinorelbine, cisplatin | Drug | – |
Primary outcome
Objective response rate
4 secondary outcomes
Overall survival
Time to progression
Relapse rate (local control)
Safety
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 10 Mar 2016.
- Results publication: PubMed 26689864Fournel P, Vergnenegre A, Robinet G, Lena H, Gervais R, Le Caer H, Souquet PJ, Chavaillon JM, Bozonnat MC, Daures JP, Chouaid C, Martel-Lafay I; GFPC and IFCT Team. Induction or consolidation chemotherapy for unresectable stage III non-small-cell lung cancer patients treated with concurrent chemoradiation: a randomised phase II trial GFPC - IFCT 02-01. Eur J Cancer. 2016 Jan;52:181-7. doi: 10.1016/j.ejca.2015.10.072. Epub 2015 Dec 12.
Related trials for NSCLC Stage IIIB
RecruitingPhase 2
Adaptive Chemotherapy for Pd-l1 High REsEctablE NSCLC: A Chemo-PHREE Trial
Nsclc, NSCLC Stage II
Active, not recruitingPhase 3
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)
PD-L1-positive, Locally Advanced (Unresectable Stage IIIB/C) or Metastatic NSCLC
Active, not recruitingPhase 2
1st Line Durvalumab in PS 2 NSCLC Patients
NSCLC Stage IV, NSCLC Stage IIIB
Active, not recruitingPhase 2
Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)
Advanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification, Lung Adenocarcinoma Stage IIIB/IV
Active, not recruitingPhase 2
Second-Line Sacituzumab Tirumotecan Plus Anlotinib for Advanced Driver Gene-Negative Non-Squamous NSCLC
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC Stage IIIB~IV
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.
Pierre Fournel, 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 Paclitaxel, vinorelbine, cisplatin in people with NSCLC Stage IIIB and Concomitant Radiochemotherapy, run by Intergroupe Francophone de Cancerologie Thoracique 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 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 10 Mar 2016. 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?
Objective response rate. 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 NCT00198432, 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 10 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.