Stage I-III Non-small Cell Lung CancerPhase 2NCT01166204
Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With Intensity-modulated Radiotherapy (IMRT) for Non Small Cell Lung Cancer (NSCLC) to an Individualised Mean Lung Dose (MLD)
A Phase 2 study testing Radiotherapy in people with Stage I-III Non-small Cell Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I-III Non-small Cell Lung Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to May 2017
- 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 proven NSCLC
- IUCC stage I-III, or solitary metastases (<6), which are amendable for radical local treatment.
- Performance status 0-2
- IMRT technique
Who cannot join
- Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- Stage IV, except for solitary (<6) metastases
- Performance status 3 or more
- No IMRT technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD
Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.
Read the detailed description
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/-1Gy, irrespective of lung function.
Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy
In concurrence with chemotherapy, radiotherapy will be delivered as follows:
- First three weeks/30 fractions: twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions
- Thereafter: once daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.
In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic
Chemotherapy schedules allowed:
- 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type will be registered.
- Concurrent part: (day 1 = first day of radiotherapy)
- cisplatin - vinorelbine
- cisplatin - docetaxel
- cisplatin - etoposide
- cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles
When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin
- Conditions
- Stage I-III Non-small Cell Lung Cancer
- Being tested
- Radiotherapy
- Keywords
- Radiotherapy, NSCLC
- 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.
RadiotherapyRadiation
Radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2.3 and 5 years
Secondary outcomes (4)
Progression-free survival
Measured: 2.3 and 5 years
Dyspnea (CTCAE 4.0)
Measured: 2.3 and 5 years
Dysphagia (CTCAE 4.0)
Measured: 2.3 and 5 years
Patterns of recurrence
Measured: 2.3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I-III 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166204
- Sponsor's protocol ID
- BRONC CONCURR MLD/BRONC MLD
- Status last verified
- May 2017
- First submitted
- 19 Jul 2010
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent and Non-concurrent Chemo-radiotherapy or Radiotherapy Alone With IMRT for Stage I-III Non-small Cell Lung Cancer to an Individualised MLD
- ClinicalTrials.gov ID
- NCT01166204
- Acronym / sponsor ID
- BRONC CONCURR MLD/BRONC MLD
- Conditions
- Stage I-III Non-small Cell Lung Cancer
- Keywords
- Radiotherapy, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 20 Jul 2010 (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.
Our group has shown that increasing the radiation dose to pre-specified normal tissue dose constraints could lead to increased TCP with the same NTCP in patients with non-concurrent and concurrent chemo-radiation. Here, the investigators want to investigate its efficacy in a prospective study in patients with stage I-III NSCLC, who are selected for high-dose radiotherapy with or without chemotherapy, but treated with IMRT. The latter technique has become standard, but the patterns of recurrence and the possibility for dose-escalation in an individualised setting have never been investigated properly.
Detailed description
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to an MLD (Mean Lung Dose) of 20 +/-1Gy, irrespective of lung function.
Other dose-constraints: spinal cord max: 54Gy, brachial plexus (Dmax):66Gy
In concurrence with chemotherapy, radiotherapy will be delivered as follows:
- First three weeks/30 fractions: twice-daily fractions of 1.5Gy, with 8h to 10h as interfraction interval, 5 days per week. Total dose: 45Gy/30 fractions
- Thereafter: once daily fractions of 2.0Gy, 5 days per week until the target dose has been reached.
In sequential or radiotherapy alone schedules, twice-daily 1.8Gy with an interfraction interval of at least 8h will be delivered.
The radiation doses will be specified according to ICRU 50. Lung density corrections will be applied, as well as all standard QA procedures. Technical requirements are the same as in standard practice at MAASTRO clinic
Chemotherapy schedules allowed:
- 1-2 cycles induction chemotherapy: any third generation schedule is allowed. The type will be registered.
- Concurrent part: (day 1 = first day of radiotherapy)
- cisplatin - vinorelbine
- cisplatin - docetaxel
- cisplatin - etoposide
- cisplatin - pemetrexed in non-squamous histologies Q 3 weeks; 3 cycles
When the calculated creatinin clearance is less than 60ml/min, cisplatin may be substituted for carboplatin
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological or cytological proven NSCLC
- IUCC stage I-III, or solitary metastases (<6), which are amendable for radical local treatment.
- Performance status 0-2
- IMRT technique
Key exclusion criteria (4 listed)
- Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- Stage IV, except for solitary (<6) metastases
- Performance status 3 or more
- No IMRT technique
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 |
|---|---|---|
| RadiotherapyRadiotherapy | Radiation | Single group |
Primary outcome
Overall survival
Time frame: 2.3 and 5 years
4 secondary outcomes
Progression-free survival
Time frame: 2.3 and 5 years
Dyspnea (CTCAE 4.0)
Time frame: 2.3 and 5 years
Dysphagia (CTCAE 4.0)
Time frame: 2.3 and 5 years
Patterns of recurrence
Time frame: 2.3 and 5 years
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 23 May 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Radiotherapy in people with Stage I-III Non-small Cell Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 4 inclusion and 4 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 23 May 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 Netherlands. 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?
Overall survival (time frame: 2.3 and 5 years). 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 23 May 2017.