Non Small Cell Lung CarcinomaPhase 2NCT00661011
Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy
A Phase 2 study testing Lobectomy followed by concomitant mediastinal chemoradiotherapy in people with Non Small Cell Lung Carcinoma, run by European Lung Cancer Working Party at 12 sites in 3 countries.
Trial summary
The purpose of this study is to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III NSCLC responding to induction chemotherapy but in which the residual disease is too large to be treated by… 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?
- Lobectomy followed by concomitant mediastinal chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jan 2007to Jun 2014
- 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
- Histological or cytological diagnosis of non-small cell carcinoma of the lung
- Initially stage III NSCLC
- Pathologically proven N2 or N3 disease
- Any response to induction chemotherapy (whatever the regimen administered)
- Disease still not fully resectable (because of extensive mediastinal N disease) and not suitable for radical radiotherapy (single field) after induction chemotherapy
- Lobectomy possible for the treatment of T disease
- Availability for participating in the detailed follow-up of the protocol
- Informed consent
Who cannot join
- Prior treatment with radiotherapy or surgery
- Karnofsky PS < 60
- Functional or anatomical contra-indication to mediastinal radiotherapy
- Functional or anatomical contra-indication to surgical lobectomy
- A 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)
- Malignant pleural or pericardial effusion
Show all 16Show fewer
- Neutrophils < 2,000/mm³
- Platelet cells < 100,000/mm3
- Serum bilirubin > 1.5 mg/100 ml
- 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)
- Congestive cardiac failure or cardiac arrhythmia requiring medical treatment
- Uncontrolled infectious disease
- Hearing loss
- Symptomatic polyneuropathy
- Serious medical or psychological factors which may prevent adherence to the treatment schedule
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Belgium10 sites
Department of Pneumology RHMS Hôpital de la Madeleine
Ath, 7800
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, 6000
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
About this study
Official title: A Phase II Study Assessing the Curative Effect of the Combination of Lobectomy Followed by Mediastinal Concomitant Radiochemotherapy in Patients With Locally Advanced Unresectable Stage III Non-small Cell Lung Cancer Responding to Induction Chemotherapy
The purpose of this study is to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III NSCLC responding to induction chemotherapy but in which the residual disease is too large to be treated by radiotherapy.
- Conditions
- Non Small Cell Lung Carcinoma
- Being tested
- Lobectomy followed by concomitant mediastinal chemoradiotherapy
- Keywords
- Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Vinorelbine, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma, Surgery, Unresectable stage III non-small cell lung carcinoma not suitable for radical radiotherapy after objective response to induction chemotherapy
- 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.
Lobectomy followed by concomitant mediastinal chemoradiotherapyProcedure or surgery
Lobectomy Radiotherapy 66 Gy in 2 Gy/ fraction, 5 fractions/wk Chemotherapy Cisplatin 60 mg/m² on days 1 and 22 and Vinorelbine 15 mg/m² on days 1, 8, 22 and 29
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Lobectomy followed by mediastinal concomitant chemoradiotherapy Receives: Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapy |
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 registration until death or last follow up
Secondary outcomes (3)
Operative mortality and morbidity
Measured: To be observed during the 30 days following the surgical procedure
Local control rate
Measured: After completion of treatment
Toxicity
Measured: After each course of chemotherapy and at the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2013
- Study completionJun 2014
Why it stopped: The study was terminated due to too 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Sculier, MD, PhD, Study chair, European Lung Cancer Working Party
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661011
- Sponsor's protocol ID
- ELCWP 01061
- Status last verified
- Feb 2015
- First submitted
- 15 Apr 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 II Study Assessing the Curative Effect of the Combination of Lobectomy Followed by Mediastinal Concomitant Radiochemotherapy in Patients With Locally Advanced Unresectable Stage III Non-small Cell Lung Cancer Responding to Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT00661011
- Acronym / sponsor ID
- ELCWP 01061
- Conditions
- Non Small Cell Lung Carcinoma
- Keywords
- Non-small cell lung carcinoma, Concomitant radiochemotherapy, Cisplatin, Vinorelbine, Radiotherapy, Chemotherapy, Unresectable stage III non-small cell lung carcinoma, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to too slow recruitment
- Enrolment
- 75 participants (actual)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Apr 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 this study is to determine if radical radiochemotherapy on the mediastinum after lobectomy can be associated with significant long term survival in patients with initially unresectable stage III NSCLC responding to induction chemotherapy but in which the residual disease is too large to be treated by radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Lobectomy followed by concomitant mediastinal chemoradiotherapyLobectomy followed by mediastinal concomitant chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological or cytological diagnosis of non-small cell carcinoma of the lung
- Initially stage III NSCLC
- Pathologically proven N2 or N3 disease
- Any response to induction chemotherapy (whatever the regimen administered)
- Disease still not fully resectable (because of extensive mediastinal N disease) and not suitable for radical radiotherapy (single field) after induction chemotherapy
Key exclusion criteria (16 listed)
- Prior treatment with radiotherapy or surgery
- Karnofsky PS < 60
- Functional or anatomical contra-indication to mediastinal radiotherapy
- Functional or anatomical contra-indication to surgical lobectomy
- A 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)
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 |
|---|---|---|
| Lobectomy followed by concomitant mediastinal chemoradiotherapyLobectomy Radiotherapy 66 Gy in 2 Gy/ fraction, 5 fractions/wk Chemotherapy Cisplatin 60 mg/m² on days 1 and 22 and Vinorelbine 15 mg/m² on days 1, 8, 22 and 29 | Procedure or surgery | A |
Primary outcome
Survival
Time frame: Survival will be dated from the day of registration until death or last follow up
3 secondary outcomes
Operative mortality and morbidity
Time frame: To be observed during the 30 days following the surgical procedure
Local control rate
Time frame: After completion of treatment
Toxicity
Time frame: After each course of chemotherapy and at the end of treatment
Results and safety
The study was stopped early (reason given: The study was terminated due to too 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 protocol)Link 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.
Jean-Paul Sculier, MD, PhD study chair
European Lung Cancer Working Party
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lobectomy followed by concomitant mediastinal chemoradiotherapy in people with Non Small Cell Lung Carcinoma, run by European Lung Cancer Working Party at 12 sites in 3 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 8 inclusion and 16 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 12 sites in Belgium, 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 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 was stopped early (reason given: The study was terminated due to too 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 registration 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.