Non-Small-Cell Lung CarcinomaPhase 2NCT00985855
Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer
A Phase 2 study testing cisplatin, vinorlebine, cetuximab and cisplatine, etoposide, cetuximab in people with Non-Small-Cell Lung Carcinoma, run by Institut de Cancérologie de la Loire at 1 site in France.
Trial summary
Phase II, randomised, controlled, non comparative study with 2 parallel groups: Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- cisplatin, vinorlebine, cetuximab and cisplatine, etoposide, cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Aug 2011
- 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
- Non-Small-Cell Lung cancer cytologically or histologically proved
- Stage III AN2 inoperable or non resectable
- presence of at least one one dimension measurable target (at least 10 mm with spiral tomodensitometry)
- Possibility to include all targets in one irradiation field
- Age of 18 to 70
- Patients non previously treated
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- Performance Status 0 or 1
- Loss of weight ≤10% in the 3 last months
- Neutrophil ≥ 1500/mm3 and platelets ≥ 100000/mm3
- Creatinine clearance ≥ 60 ml/min
- total bilirubin ≤ 1,5N and ASAT ALAT ≤ 2,5N
- Respiratory function normal: VEMS ≥ 40% theorical, DLCO/VA ≥ 50% theorical and PaO2 ≥ 60 mmHg
- Signed inform consent form
- Compliance to radiotherapy 66 Gy with dosimetry V20 ≤ 35% and pulmonary mean dose≤20 Gy
Who cannot join
- Pretreated bronchial carcinoma, excepted endoscopic deobstruction
- operable bronchial carcinoma
- small cell lung cancer, composite cancer, neuroendocrine cancer, broncho alveolar cancer
- superior vena cava syndroms
- puncturable pleural effusion
- metastatic lung cancer
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- Stage IIIb cancer with neoplastic pericarditis
- Previous thoracic irradiation
- severe cardiac disease in the 12 months before inclusion
- interstitial lung disease
- anti-EGFR and anti-VEGF treatments
- hypersensitivity to murine proteins and allergies to protocol drugs
- uncontrolled infectious state
- HIV patient
- corticoid definitive contraindication
- péripheric neuropathy grade≥2
- neurologic, psychiatric and organic disorder
- past or concomitant cancer excepted treated skin baso-cellular cancer or in situ cervical cancer, or any cancer only surgically treated for 5 years
- breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study
Phase II, randomised, controlled, non comparative study with 2 parallel groups:
- Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
- Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- cisplatin, vinorlebine, cetuximab, cisplatine, etoposide, cetuximab
- 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, vinorlebine, cetuximabDrug
patient will receive 2 cycles of cisplatine 80 mg/m² at day 29 and day 50 more vinorelbine 15 mg/m² at day 29, day 36 and day 50 and 57 associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71
cisplatine, etoposide, cetuximabDrug
patient will receive 2 cycles of cisplatine 50 mg/m² at day 29, 36, 57, and 64 + étoposide 50mg/m² during day 29-33, day 57-61associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin, vinorelbine | Experimental | patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy. Receives: Drug: cisplatin, vinorlebine, cetuximab |
| Cisplatin, etoposide | Experimental | patients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy. Receives: Drug: cisplatine, etoposide, cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)
Measured: End of concomitant treatment (Day 71)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre FOURNEL, Dr, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985855
- Sponsor's protocol ID
- 2008-03
- Other IDs
- 2008-005013-21, 2008
- Status last verified
- Jan 2011
- First submitted
- 22 Sep 2009
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study
- ClinicalTrials.gov ID
- NCT00985855
- Acronym / sponsor ID
- 2008-03
- Conditions
- Non-Small-Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 29 Sep 2009 (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.
Phase II, randomised, controlled, non comparative study with 2 parallel groups:
- Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy.
- Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisplatin, vinorelbine | Experimental | Drug: cisplatin, vinorlebine, cetuximabpatients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy. |
| Cisplatin, etoposide | Experimental | Drug: cisplatine, etoposide, cetuximabpatients will receive induction chemotherapy (cisplatin, docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Non-Small-Cell Lung cancer cytologically or histologically proved
- Stage III AN2 inoperable or non resectable
- presence of at least one one dimension measurable target (at least 10 mm with spiral tomodensitometry)
- Possibility to include all targets in one irradiation field
- Age of 18 to 70
Key exclusion criteria (19 listed)
- Pretreated bronchial carcinoma, excepted endoscopic deobstruction
- operable bronchial carcinoma
- small cell lung cancer, composite cancer, neuroendocrine cancer, broncho alveolar cancer
- superior vena cava syndroms
- puncturable pleural effusion
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, vinorlebine, cetuximabpatient will receive 2 cycles of cisplatine 80 mg/m² at day 29 and day 50 more vinorelbine 15 mg/m² at day 29, day 36 and day 50 and 57 associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71 | Drug | Cisplatin, vinorelbine |
| cisplatine, etoposide, cetuximabpatient will receive 2 cycles of cisplatine 50 mg/m² at day 29, 36, 57, and 64 + étoposide 50mg/m² during day 29-33, day 57-61associated to cetuximab 400 mg/m² at day: 22,29, 36, 43, 50, 57, 64 and 71 | Drug | Cisplatin, etoposide |
Primary outcome
rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting)
Time frame: End of concomitant treatment (Day 71)
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 14 Sep 2017.
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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.
Pierre FOURNEL, Dr principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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, vinorlebine, cetuximab and cisplatine, etoposide, cetuximab in people with Non-Small-Cell Lung Carcinoma, run by Institut de Cancérologie de la Loire 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 14 inclusion and 19 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 14 Sep 2017. 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?
rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting) (time frame: End of concomitant treatment (Day 71)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2017.