Non-small Cell Lung CancerBRONC CONC MLDNCT00572325
Concurrent Chemo-radiation Form NSCLC to a Individualized MLD
An observational study of Non-small Cell Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with non-concurrent chemo-radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- Type of treatment
- Injection or infusion
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2006to May 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Histological or cytological proven NSCLC * UICC stage I-III * Performance status 0-2 * FeV 1 and DLCO at least 30% of the age-predicted value
Who may be able to join
- Histological or cytological proven NSCLC
- UICC stage I-III
- Performance status 0-2
- FeV 1 and DLCO at least 30% of the age-predicted value
Who cannot join
- Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- UICC stage IV
- Performance status 3 or more
- FeV 1 and DLCO < 30% of the age-predicted value
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
MAASTRO clinic, Maastricht Radiation Oncology
Maastricht, 6202 AZ
About this study
Official title: Concurrent Chemo-radiotherapy for Stage III Non-small Cell Lung Cancer ta an Individualized MLD
Our group has shown in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to investigate its efficacy in a prospective study in patients with stage III NSCLC, who are selected for radical concurrent radiotherapy
Read the detailed description
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):
- MLD=19 Gy when Fev1 and DLCO>50% of the predicted value
- MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value
- MLD=10 Gy when Fev1 and/or DLCO <40% of the predicted value
Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:54 Gy. Maximal tumor dose:69 Gy
Radiotherapy will be delivered as follows:
- First 3 weeks: 30 fractions: twice-daily fractions of 1.5 Gy, with 8 to 10 h as interfraction-interval, 5 days per week Total dose;45Gy/30 fractions
- Thereafter: once-daily fractions of 2.0 Gy, 5 days per week until the target dose has been reached.
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 type will be registered.
- concurrent part:(day1= first day of radiotherapy)
- cisplatin - vinorelbine
- Cisplatin 50 mg/m2 day 2 and day 9
- Vinorelbine 20 mg/m2 day 2 and day 9
- Cisplatin 40mg/m2 day 23
- Vinorelbine 15mg/m2 day 23 and day 30
- cisplatin - docetaxel
- Cisplatin 50 mg/m2 day 2,9 and 29
- Docetaxel 20 mg/m2 day 2, 9, 16, 23 and 29
- cisplatin - etoposide
- Cisplatin 60 mg/m2 day 1
- Docetaxel 120 mg/m2 day 1-3
Q 3 weeks, 3 cycles
When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- radiotherapy, NSCLC, stage III 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 |
|---|---|---|
| 1 | Inclusion criteria * Histological or cytological proven NSCLC * UICC stage I-III * Performance status 0-2 * FeV1 and DLCO at least 30% of age-predicted value Exclusion criteria: * Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma) * stage IV * performance status 3 or more * FeV 1 or DLCO< 30% of the age-predicted value |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Measured: 2,3 and 5 years
Secondary outcomes (1)
-progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -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 posted13 Dec 2007 (estimated)
- Study startAug 2006
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Investigators
- Dirk De Ruysscher, MD,PhD, Principal investigator, MAASTRO clinic, Maastricht Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572325
- Sponsor's protocol ID
- BRONC CONCURR MLD
- Acronym
- BRONC CONC MLD
- Status last verified
- Jul 2010
- First submitted
- 12 Dec 2007
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Nalbantov G, Kietselaer B, Vandecasteele K, Oberije C, Berbee M, Troost E, Dingemans AM, van Baardwijk A, Smits K, Dekker A, Bussink J, De Ruysscher D, Lievens Y, Lambin P. Cardiac comorbidity is an independent risk factor for radiation-induced lung toxicity in lung cancer patients. Radiother Oncol. 2013 Oct;109(1):100-6. doi: 10.1016/j.radonc.2013.08.035. Epub 2013 Sep 14.
PubMed 24044794van Baardwijk A, Reymen B, Wanders S, Borger J, Ollers M, Dingemans AM, Bootsma G, Geraedts W, Pitz C, Lunde R, Peters F, Lambin P, De Ruysscher D. Mature results of a phase II trial on individualised accelerated radiotherapy based on normal tissue constraints in concurrent chemo-radiation for stage III non-small cell lung cancer. Eur J Cancer. 2012 Oct;48(15):2339-46. doi: 10.1016/j.ejca.2012.04.014. Epub 2012 May 18.
PubMed 22608261Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, van der Weide H, Rao B, Lambin P. Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-8. doi: 10.1016/j.ijrobp.2010.06.011. Epub 2010 Oct 1.
PubMed 20888135
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemo-radiotherapy for Stage III Non-small Cell Lung Cancer ta an Individualized MLD
- ClinicalTrials.gov ID
- NCT00572325
- Acronym / sponsor ID
- BRONC CONC MLD / BRONC CONCURR MLD
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- radiotherapy, NSCLC, stage III non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- May 2009 (actual)
- First posted
- 13 Dec 2007 (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 in a modeling study that increasing the radiation dose to pre-specified normal tissue dose constrains could lead to increased TCP with the same NTCP in patients with non-concurrent chemo-radiation. In a subsequent phase I trial, in patients receiving non-concurrent chemo-radiation we showed the safety of this approach. Here,we want to investigate its efficacy in a prospective study in patients with stage III NSCLC, who are selected for radical concurrent radiotherapy
Detailed description
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes to the following MLD (Mean Lung Dose):
- MLD=19 Gy when Fev1 and DLCO>50% of the predicted value
- MLD=15 Gy when Fev1 and/or DLCO 40-49% of the predicted value
- MLD=10 Gy when Fev1 and/or DLCO <40% of the predicted value
Other dose-constrains: spinal cord max: 54 Gy, brachial plexus (Dmax):66 Gy Minimum tumor dose:54 Gy. Maximal tumor dose:69 Gy
Radiotherapy will be delivered as follows:
- First 3 weeks: 30 fractions: twice-daily fractions of 1.5 Gy, with 8 to 10 h as interfraction-interval, 5 days per week Total dose;45Gy/30 fractions
- Thereafter: once-daily fractions of 2.0 Gy, 5 days per week until the target dose has been reached.
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 type will be registered.
- concurrent part:(day1= first day of radiotherapy)
- cisplatin - vinorelbine
- Cisplatin 50 mg/m2 day 2 and day 9
- Vinorelbine 20 mg/m2 day 2 and day 9
- Cisplatin 40mg/m2 day 23
- Vinorelbine 15mg/m2 day 23 and day 30
- cisplatin - docetaxel
- Cisplatin 50 mg/m2 day 2,9 and 29
- Docetaxel 20 mg/m2 day 2, 9, 16, 23 and 29
- cisplatin - etoposide
- Cisplatin 60 mg/m2 day 1
- Docetaxel 120 mg/m2 day 1-3
Q 3 weeks, 3 cycles
When the calculated creatinin clearance is less than 60 ml/min, cisplatin may be substituted for carboplatin
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Inclusion criteria * Histological or cytological proven NSCLC * UICC stage I-III * Performance status 0-2 * FeV1 and DLCO at least 30% of age-predicted value Exclusion criteria: * Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma) * stage IV * performance status 3 or more * FeV 1 or DLCO< 30% of the age-predicted value |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Histological or cytological proven NSCLC * UICC stage I-III * Performance status 0-2 * FeV 1 and DLCO at least 30% of the age-predicted value
Key inclusion criteria (4 listed)
- Histological or cytological proven NSCLC
- UICC stage I-III
- Performance status 0-2
- FeV 1 and DLCO at least 30% of the age-predicted value
Key exclusion criteria (4 listed)
- Not NSCLC or mixed NSCLC and other histologies (e.g. small cell carcinoma)
- UICC stage IV
- Performance status 3 or more
- FeV 1 and DLCO < 30% of the age-predicted value
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
death
Time frame: 2,3 and 5 years
1 secondary outcome
-progression-free interval -Dyspnea (CTCAE 3.0) -Dysphagia (CTCAE 3.0) -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 21 Jul 2010.
- Derived from this study: PubMed 24044794Nalbantov G, Kietselaer B, Vandecasteele K, Oberije C, Berbee M, Troost E, Dingemans AM, van Baardwijk A, Smits K, Dekker A, Bussink J, De Ruysscher D, Lievens Y, Lambin P. Cardiac comorbidity is an independent risk factor for radiation-induced lung toxicity in lung cancer patients. Radiother Oncol. 2013 Oct;109(1):100-6. doi: 10.1016/j.radonc.2013.08.035. Epub 2013 Sep 14.
- Derived from this study: PubMed 22608261van Baardwijk A, Reymen B, Wanders S, Borger J, Ollers M, Dingemans AM, Bootsma G, Geraedts W, Pitz C, Lunde R, Peters F, Lambin P, De Ruysscher D. Mature results of a phase II trial on individualised accelerated radiotherapy based on normal tissue constraints in concurrent chemo-radiation for stage III non-small cell lung cancer. Eur J Cancer. 2012 Oct;48(15):2339-46. doi: 10.1016/j.ejca.2012.04.014. Epub 2012 May 18.
- Derived from this study: PubMed 20888135Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, van der Weide H, Rao B, Lambin P. Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-8. doi: 10.1016/j.ijrobp.2010.06.011. Epub 2010 Oct 1.
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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.
Dirk De Ruysscher, MD,PhD principal investigator
MAASTRO clinic, Maastricht Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 21 Jul 2010. 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.
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?
death (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?
On the ClinicalTrials.gov record for NCT00572325, which also lists 3 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 21 Jul 2010.