Non Small Cell Lung CancerNCT04257864
Bevacizumab Versus Docetaxel/Erlotinib on Tumor Metrics in Patients With Previously Untreated Advanced Non Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Hellenic Cooperative Oncology Group.
Trial summary
To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jun 2014
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with non small cell lung cancer evaluated with Computed Scan or Magnetic Resonance Imaging.
Who may be able to join
- Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic non small cell lung cancer will be enrolled.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
- Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).
Who cannot join
- 1. Patients who have undergone complete tumor resection after responding to platinum based chemotherapy.
About this study
Official title: Impact of Bevacizumab Versus Docetaxel/Erlotinib on Tumor Metrics in Patients With Previously Untreated Advanced Non Small Cell Lung Cancer: A Study by the Hellenic Co-operative Oncology Group
To determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer.
Read the detailed description
In 2008, the Hellenic Co-operative Oncology group (HeCOG) initiated a randomized phase II study to determine the comparative efficacy of intermittent docetaxel/erlotinib chemotherapy, with erlotinib given for twelve consecutive days either before (group A) or after (group B) docetaxel, in chemotherapy-naive patients with advanced non small cell lung cancer. Docetaxel chemotherapy was considered one of the valid non-platinum containing therapeutic options at that time and today represents one of the approved second-line treatment options after failure of first-line platinum based chemotherapy. The trial was terminated early due to slow accrual after enrollment of 51 patients and was published in 2014, showing no clinically meaningful difference between the two treatment arms.
Based on the aforementioned trial population,a parallel radiological study was conducted, evaluating sequential tumor metrics on computed tomography performed at baseline and after each cycle of treatment in patients receiving either bevacizumab or docetaxel/erlotinib. Given the differential mechanism of action of these agents, it was hypothesized that the different parameters of radiological tumor response evaluation, namely the maximum diameter, tumor volume and tumor density, would respond differently for each therapeutic category (a chemotherapeutic agent, a molecular agent and and an anti-angiogenic agent). For bevacizumab, in particular, it was hypothesized that its unique mechanism of action, inducing central tumor necrosis and subsequent shrinkage, would lead to completely different tumor metrics as compared to the other two agents. Herein the final results of this analysis are presented, showing the comparison of the three agents in terms of tumor response metrics, as evaluated in CT scans performed at baseline and after each cycle of treatment
- Conditions
- Non Small Cell Lung Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib followed by docetaxel | Erlotinib given for twelve consecutive days before docetaxel | |
| Docetaxel followed by erlotinib | Erlotinib given for twelve consecutive days after docetaxel | |
| Bevacizumab treated | Bevacizumab treated patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Evaluation of response using RECIST 1.1 criteria (REF) was based on the measurement of a total of 5 measurable lesions.
Measured: Every 12 -16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study startNov 2008
- Primary completionMay 2010
- Study completionJun 2014
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 CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257864
- Sponsor's protocol ID
- Neo-Doperlo
- Status last verified
- Feb 2020
- First submitted
- 4 Feb 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bevacizumab Versus Docetaxel/Erlotinib on Tumor Metrics in Patients With Previously Untreated Advanced Non Small Cell Lung Cancer: A Study by the Hellenic Co-operative Oncology Group
- ClinicalTrials.gov ID
- NCT04257864
- Acronym / sponsor ID
- Neo-Doperlo
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Feb 2020 (actual)
- 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 determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced Non-Small-Lung-Cancer.
Detailed description
In 2008, the Hellenic Co-operative Oncology group (HeCOG) initiated a randomized phase II study to determine the comparative efficacy of intermittent docetaxel/erlotinib chemotherapy, with erlotinib given for twelve consecutive days either before (group A) or after (group B) docetaxel, in chemotherapy-naive patients with advanced non small cell lung cancer. Docetaxel chemotherapy was considered one of the valid non-platinum containing therapeutic options at that time and today represents one of the approved second-line treatment options after failure of first-line platinum based chemotherapy. The trial was terminated early due to slow accrual after enrollment of 51 patients and was published in 2014, showing no clinically meaningful difference between the two treatment arms.
Based on the aforementioned trial population,a parallel radiological study was conducted, evaluating sequential tumor metrics on computed tomography performed at baseline and after each cycle of treatment in patients receiving either bevacizumab or docetaxel/erlotinib. Given the differential mechanism of action of these agents, it was hypothesized that the different parameters of radiological tumor response evaluation, namely the maximum diameter, tumor volume and tumor density, would respond differently for each therapeutic category (a chemotherapeutic agent, a molecular agent and and an anti-angiogenic agent). For bevacizumab, in particular, it was hypothesized that its unique mechanism of action, inducing central tumor necrosis and subsequent shrinkage, would lead to completely different tumor metrics as compared to the other two agents. Herein the final results of this analysis are presented, showing the comparison of the three agents in terms of tumor response metrics, as evaluated in CT scans performed at baseline and after each cycle of treatment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erlotinib followed by docetaxel | – | –Erlotinib given for twelve consecutive days before docetaxel |
| Docetaxel followed by erlotinib | – | –Erlotinib given for twelve consecutive days after docetaxel |
| Bevacizumab treated | – | –Bevacizumab treated patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with non small cell lung cancer evaluated with Computed Scan or Magnetic Resonance Imaging.
Key inclusion criteria (3 listed)
- Male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic non small cell lung cancer will be enrolled.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
- Presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease).
Key exclusion criteria (1 listed)
- 1. Patients who have undergone complete tumor resection after responding to platinum based chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor response
Time frame: Every 12 -16 weeks
Evaluation of response using RECIST 1.1 criteria (REF) was based on the measurement of a total of 5 measurable lesions.
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 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Hellenic Cooperative Oncology Group.
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 3 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Tumor response (time frame: Every 12 -16 weeks). 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 10 Feb 2020.