Small Cell Lung CancerBRONC 45 15NCT00572923
Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans
An observational study of Small Cell Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Our group has shown that the omission of elective nodal irradiation on the basis of CT scans in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2006to Feb 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 SCLC * UICC stage I-III, "limited disease" * 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 SCLC
- UICC stage I-III, "limited disease"
- Performance status 0-2
- FeV 1 and DLCO at least 30% of the age-predicted value
Who cannot join
- Not SCLC or mixed SCLC and other histologies (e.g. non-small cell lung 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
Our group has shown that the omission of elective nodal irradiation on the basis of CT scans in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. We have previously also shown that selective mediastinal nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will investigate the safety of selective nodal irradiation in LD-SCLC patients treated with concurrent chemo-radiation.
Read the detailed description
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on FDG-PET scan to a dose of 45 Gy in 30 fractions in 3 weeks (1.5 Gy BID with minimum 6 h interfraction interval).
Dose-constraints: MLD > 20 Gy. In that case, CT-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate.
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.
Radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy.
Chemotherapy (standard schedule in the Comprehensive Cancer Centre Limburg region):
- carboplatin AUC 5 day 1
- etoposide 120 mg/m2 days 1-3
Q 3 weeks; 5 cycles
In patients with no progression and a WHO PS 0-2, after the completion of chemotherapy, PCI will be given (25 Gy in 10 fractions, QD)
- Conditions
- Small Cell Lung Cancer
- Keywords
- radiotherapy, LD-SCLC, stage I-III small cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma
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 SCLC * UICC stage I-III, "limited disease" * Performance status 0-2 * FeV1 and DLCO at least 30% of age-predicted value Exclusion criteria: * Not SCLC or mixed SCLC and other histologies (e.g. non-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.
isolated Nodal Recurrences
Measured: 18 months post-treatment
Secondary outcomes (5)
overall survival
Measured: 18 months post-treatment
progression-free interval
Measured: 18 months post-treatment
dyspnea (CTCAE 3.0)
Measured: 18 months post-treatment
dysphagia (CTCAE 3.0)
Measured: 18 months post-treatment
patterns of recurrence
Measured: 18 months post-treatment
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 completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 52 participants (estimated)
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
- NCT00572923
- Sponsor's protocol ID
- BRONC 45, 1.5
- Acronym
- BRONC 45 15
- Status last verified
- Jun 2009
- First submitted
- 12 Dec 2007
- Last updated
- 17 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemo-Radiotherapy for Limited Disease Small Cell Lung Cancer (LD-SCLC) on Basis of FDG-PET-Scans
- ClinicalTrials.gov ID
- NCT00572923
- Acronym / sponsor ID
- BRONC 45 15 / BRONC 45, 1.5
- Conditions
- Small Cell Lung Cancer
- Keywords
- radiotherapy, LD-SCLC, stage I-III small cell lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Feb 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 that the omission of elective nodal irradiation on the basis of CT scans in patients with LD-SCLC lead to a higher than expected isolated nodal recurrence in the ipsilateral supraclavicular area. We have previously also shown that selective mediastinal nodal radiation on basis of FDG-PET scans in NSCLC is safe and reduces the radiation fields and hence toxicity. As the accuracy of FDG-PET scans is also in SCLC higher than CT, we will investigate the safety of selective nodal irradiation in LD-SCLC patients treated with concurrent chemo-radiation.
Detailed description
Eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on FDG-PET scan to a dose of 45 Gy in 30 fractions in 3 weeks (1.5 Gy BID with minimum 6 h interfraction interval).
Dose-constraints: MLD > 20 Gy. In that case, CT-based replanning will be done after 1 week of treatment and shrinking field techniques will be used if appropriate.
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.
Radiotherapy shall start during the first cycle of carboplatin and etoposide chemotherapy.
Chemotherapy (standard schedule in the Comprehensive Cancer Centre Limburg region):
- carboplatin AUC 5 day 1
- etoposide 120 mg/m2 days 1-3
Q 3 weeks; 5 cycles
In patients with no progression and a WHO PS 0-2, after the completion of chemotherapy, PCI will be given (25 Gy in 10 fractions, QD)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Inclusion criteria * Histological or cytological proven SCLC * UICC stage I-III, "limited disease" * Performance status 0-2 * FeV1 and DLCO at least 30% of age-predicted value Exclusion criteria: * Not SCLC or mixed SCLC and other histologies (e.g. non-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 SCLC * UICC stage I-III, "limited disease" * 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 SCLC
- UICC stage I-III, "limited disease"
- Performance status 0-2
- FeV 1 and DLCO at least 30% of the age-predicted value
Key exclusion criteria (4 listed)
- Not SCLC or mixed SCLC and other histologies (e.g. non-small cell lung 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
isolated Nodal Recurrences
Time frame: 18 months post-treatment
5 secondary outcomes
overall survival
Time frame: 18 months post-treatment
progression-free interval
Time frame: 18 months post-treatment
dyspnea (CTCAE 3.0)
Time frame: 18 months post-treatment
dysphagia (CTCAE 3.0)
Time frame: 18 months post-treatment
patterns of recurrence
Time frame: 18 months post-treatment
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 17 Jun 2009.
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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 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 17 Jun 2009. 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?
isolated Nodal Recurrences (time frame: 18 months post-treatment). 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 17 Jun 2009.