Non Small Cell Lung CarcinomaNCT00864266
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer
A study testing Chemotherapy in people with Non Small Cell Lung Carcinoma, run by European Lung Cancer Working Party at 6 sites in Belgium.
Trial summary
The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques. 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?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesBelgium
- Study dates
- Mar 2009to Jun 2020
- Phase
- Interventional
- 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 diagnosis of non-small-cell lung cancer (NSCLC)
- Obtention of a biopsy of the tumour according to the procedure defined in the protocol
- NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)
- Presence of at least one assessable lesion
- Availability for participating in the detailed follow-up of the protocol
- Signed informed consent.
- Age above 18 years
Who cannot join
- Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC
- NSCLC treated by exclusive surgery or radiotherapy
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
Department of Pneumology Clinique Saint-Luc
Bouge, 5004
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
Service de Pneumologie Hôpital Erasme
Brussels, 1070
Department of Pneumology Hôpital Saint-Joseph
Gilly, 6060
Hôpital Ambroise Paré
Mons, 7000
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, 7700
About this study
Official title: Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study
The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.
- Conditions
- Non Small Cell Lung Carcinoma
- Being tested
- Chemotherapy
- Keywords
- Non small cell lung carcinoma, Chemotherapy, Response prediction
- 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.
ChemotherapyDrug
Standard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | After obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org) Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: response will be assessed every 3 cycles of chemotherapy according to WHO criteria
Secondary outcomes (3)
Survival
Measured: Survival will be dated from the date of treatment
Progression-free survival
Measured: Period between the date of treatment and the date of first progression or death
Duration of response
Measured: period between the day of treatment and the date of first progression in patients with an objective response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
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
- NCT00864266
- Sponsor's protocol ID
- 01082
- Status last verified
- Jun 2020
- First submitted
- 16 Mar 2009
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Berghmans T, Ameye L, Lafitte JJ, Colinet B, Cortot A, CsToth I, Holbrechts S, Lecomte J, Mascaux C, Meert AP, Paesmans M, Richez M, Scherpereel A, Tulippe C, Willems L, Dernies T, Leclercq N, Sculier JP; European Lung Cancer Working Party. Prospective Validation Obtained in a Similar Group of Patients and with Similar High Throughput Biological Tests Failed to Confirm Signatures for Prediction of Response to Chemotherapy and Survival in Advanced NSCLC: A Prospective Study from the European Lung Cancer Working Party. Front Oncol. 2015 Jan 28;4:386. doi: 10.3389/fonc.2014.00386. eCollection 2014.
PubMed 25674536Berghmans T, Ameye L, Willems L, Paesmans M, Mascaux C, Lafitte JJ, Meert AP, Scherpereel A, Cortot AB, Cstoth I, Dernies T, Toussaint L, Leclercq N, Sculier JP; European Lung Cancer Working Party. Identification of microRNA-based signatures for response and survival for non-small cell lung cancer treated with cisplatin-vinorelbine A ELCWP prospective study. Lung Cancer. 2013 Nov;82(2):340-5. doi: 10.1016/j.lungcan.2013.07.020. Epub 2013 Aug 7.
PubMed 24007627
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer : a Prospective Study
- ClinicalTrials.gov ID
- NCT00864266
- Acronym / sponsor ID
- 01082
- Conditions
- Non Small Cell Lung Carcinoma
- Keywords
- Non small cell lung carcinoma, Chemotherapy, Response prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- Mar 2009 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 18 Mar 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.
The primary aim of the study is to identify a predictive molecular signature for response to chemotherapy, according to WHO criteria, in patients with non-small cell lung cancer by studying the transcriptome (miRNAs and mRNAs) and the single nucleotide polymorphism (SNPs) by using high throughput techniques.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ChemotherapyAfter obtaining the biopsy, patients will be treated by standard chemotherapy (the regimen has to be in agreement with the ELCWP guidelines, available on the website www.elcwp.org) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological diagnosis of non-small-cell lung cancer (NSCLC)
- Obtention of a biopsy of the tumour according to the procedure defined in the protocol
- NSCLC of any stage to be treated by standard conventional first-line chemotherapy, as defined in the ELCWP guidelines (www.elcwp.org)
- Presence of at least one assessable lesion
- Availability for participating in the detailed follow-up of the protocol
Key exclusion criteria (3 listed)
- Patient who was previously treated with chemotherapy for NSCLC or who has any contra-indication precluding the administration of conventional chemotherapy for NSCLC
- NSCLC treated by exclusive surgery or radiotherapy
- A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder 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 |
|---|---|---|
| ChemotherapyStandard cisplatin-based chemotherapy in agreement with the ELCWP guidelines (available on the website www.elcwp.org) | Drug | 1 |
Primary outcome
Response rate
Time frame: response will be assessed every 3 cycles of chemotherapy according to WHO criteria
3 secondary outcomes
Survival
Time frame: Survival will be dated from the date of treatment
Progression-free survival
Time frame: Period between the date of treatment and the date of first progression or death
Duration of response
Time frame: period between the day of treatment and the date of first progression in patients with an objective response
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 26 Jun 2020.
- Derived from this study: PubMed 25674536Berghmans T, Ameye L, Lafitte JJ, Colinet B, Cortot A, CsToth I, Holbrechts S, Lecomte J, Mascaux C, Meert AP, Paesmans M, Richez M, Scherpereel A, Tulippe C, Willems L, Dernies T, Leclercq N, Sculier JP; European Lung Cancer Working Party. Prospective Validation Obtained in a Similar Group of Patients and with Similar High Throughput Biological Tests Failed to Confirm Signatures for Prediction of Response to Chemotherapy and Survival in Advanced NSCLC: A Prospective Study from the European Lung Cancer Working Party. Front Oncol. 2015 Jan 28;4:386. doi: 10.3389/fonc.2014.00386. eCollection 2014.
- Derived from this study: PubMed 24007627Berghmans T, Ameye L, Willems L, Paesmans M, Mascaux C, Lafitte JJ, Meert AP, Scherpereel A, Cortot AB, Cstoth I, Dernies T, Toussaint L, Leclercq N, Sculier JP; European Lung Cancer Working Party. Identification of microRNA-based signatures for response and survival for non-small cell lung cancer treated with cisplatin-vinorelbine A ELCWP prospective study. Lung Cancer. 2013 Nov;82(2):340-5. doi: 10.1016/j.lungcan.2013.07.020. Epub 2013 Aug 7.
- (Click here for more information on the protocol)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy in people with Non Small Cell Lung Carcinoma, run by European Lung Cancer Working Party at 6 sites in Belgium.
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 3 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 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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.
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?
Response rate (time frame: response will be assessed every 3 cycles of chemotherapy according to WHO criteria). 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 NCT00864266, which also lists 2 linked publications.
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 26 Jun 2020.