Non-small Cell Lung CarcinomaPhase 3NCT00633568
Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer
A Phase 3 study testing Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel and Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel in people with Non-small Cell Lung Carcinoma, run by European Lung Cancer Working Party at 19 sites in 4 countries.
Trial summary
The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Carcinoma
- What is being tested?
- Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel and Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 19 sitesin 4 countries
- Study dates
- Jan 2007to Feb 2015
- Phase
- Phase 3
- 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
- Histological or cytological diagnosis of non-small cell carcinoma of the lung
- Initially unresectable non-metastatic stage III disease
- Availability for participating in the detailed follow-up of the protocol
- Presence of an evaluable or measurable lesion
- Written informed consent
- No functional or anatomical contraindication to chest irradiation
Who cannot join
- Prior treatment with chemotherapy, radiotherapy or surgery
- Performance status < 60 on the Karnofsky scale
- History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
- Neutrophils < 2,000/mm³
- Platelet cells < 100,000/mm3
- Serum bilirubin > 1.5 mg/100 ml
Show all 19Show fewer
- Hepatic disease contra-indicating the administration of docetaxel and/or GOT or GPT ≥ 2.5x the normal value and/or alkaline phosphatase ≥ 5x the normal value
- Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
- Recent myocardial infarction (less than 3 months prior to date of diagnosis) or uncontrolled angina pectoris
- Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
- Uncontrolled infectious disease
- Symptomatic polyneuropathy
- Auditive impairment contra-indicating cisplatin administration
- Serious medical or psychological factors which may prevent adherence to the treatment schedule
- Malignant pleural or pericardial effusion
- Homolateral supraclavicular lymph node excepting upper lobe lesion
- Heterolateral supraclavicular lymph node
- Known hypersensitivity to docetaxel or cisplatin
- Pregnancy or for pre-menopausal patient, incapacity to use adequate contraceptive method
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
Belgium11 sites
Department of Pneumology RHMS Hôpital de la Madeleine
Ath, 7800
Department of Pneumology Clinique Saint-Luc
Bouge, 5004
Department of Pneumology CHR St Joseph-Warquignies
Boussu, 7360
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
Department of Pneumology Hospital Ixelles-Molière
Brussels
Department of Pneumology CHU Charleroi
Charleroi
Department of Pneumology Hôpital Saint-Joseph
Gilly, 6060
Hôpital Ambroise Paré
Mons, 7000
Hôpital Vésale - Montigny-le-Tilleul
Montigny-le-Tilleul, 6110
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, 7700
CH Peltzer-La Tourelle
Verviers, 4800
France6 sites
Service de Pneumologie Centre Hospitalier de Douai
Douai, 59507
Service de Pneumologie Hôpital de Hayange
Hayange, 57700
Pneumology department of CHU Lille
Lille
Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil
Montfermeil, 93370
Service de Pneumologie CHG Tourcoing
Tourcoing, 59208
Cabinet médical Saint-Michel
Valenciennes, 59300
About this study
Official title: A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.
The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.
- Conditions
- Non-small Cell Lung Carcinoma
- Being tested
- Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel, Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel
- Keywords
- Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Docetaxel, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma
- 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.
Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and DocetaxelDrug
Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and DocetaxelDrug
Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | One course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy Receives: Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel |
| B | Experimental | Three courses of induction chemotherapy followed by consolidation chemoradiotherapy Receives: Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Survival will be dated from the day of randomisation until death or last follow up
Secondary outcomes (3)
Response rate
Measured: At the end of the whole treatment
Toxicity
Measured: After each course of chemotherapy and at the end of treatment
Local control rate
Measured: After completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2014
- Study completionFeb 2015
Why it stopped: Slow recruitment
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Berghmans, MD, Study chair, European Lung Cancer Working Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633568
- Sponsor's protocol ID
- ELCWP 01063
- Status last verified
- Feb 2015
- First submitted
- 5 Mar 2008
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00633568
- Acronym / sponsor ID
- ELCWP 01063
- Conditions
- Non-small Cell Lung Carcinoma
- Keywords
- Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Docetaxel, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 125 participants (actual)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Mar 2008 (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.
The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and DocetaxelOne course of chemotherapy with cisplatin and docetaxel followed by induction chemoradiotherapy followed by two courses of consolidation chemotherapy |
| B | Experimental | Drug: Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and DocetaxelThree courses of induction chemotherapy followed by consolidation chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological or cytological diagnosis of non-small cell carcinoma of the lung
- Initially unresectable non-metastatic stage III disease
- Availability for participating in the detailed follow-up of the protocol
- Presence of an evaluable or measurable lesion
- Written informed consent
Key exclusion criteria (19 listed)
- Prior treatment with chemotherapy, radiotherapy or surgery
- Performance status < 60 on the Karnofsky scale
- History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or cured malignant tumour (more than 5 year disease-free interval)
- Neutrophils < 2,000/mm³
- Platelet cells < 100,000/mm3
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 |
|---|---|---|
| Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and DocetaxelConcurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1 | Drug | A |
| Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and DocetaxelConcurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1 | Drug | B |
Primary outcome
Survival
Time frame: Survival will be dated from the day of randomisation until death or last follow up
3 secondary outcomes
Response rate
Time frame: At the end of the whole treatment
Toxicity
Time frame: After each course of chemotherapy and at the end of treatment
Local control rate
Time frame: After completion of treatment
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2015.
- Click here for more information on the protocolLink provided by the sponsor.
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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.
Thierry Berghmans, MD study chair
European Lung Cancer Working Party
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel and Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel in people with Non-small Cell Lung Carcinoma, run by European Lung Cancer Working Party at 19 sites in 4 countries.
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 6 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: stopped early, as of the sponsor's last update on 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Belgium, France, Greece, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Survival (time frame: Survival will be dated from the day of randomisation until death or last follow up). 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 12 Feb 2015.