Low Grade GliomaROCOCO LGGNCT02607397
ROCOCO - Low Grade Glioma - Planning Study
An observational study of Low Grade Glioma, run by Maastricht Radiation Oncology at 4 sites in 2 countries.
Trial summary
The cost of particle therapy (PT) are considerably higher than conventional radiotherapy (RT) with photons. Considering potential dosimetric advantages of PT, it is necessary to determine if PT are more cost-effective than photons per indication regarding quality of life, survival, and progression free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Grade Glioma
- How many people
- 25 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2015to Mar 2017
- 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: 25 patients. Each patient will function as his or her own control.
Who may be able to join
- Low Grade Glioma patients
- Treated with radical intent
Who cannot join
- No Low Grade Glioma
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
University of Heidelberg
Heidelberg
University Hospital Giessen and Marburg
Marburg
Netherlands2 sites
Radiotherapy Group
Deventer
University Medical Center Nijmegen
Nijmegen
About this study
Official title: In Silico Clinical Trial on Irradiation Low Grade Glioma, Comparing Photon and Proton Therapy: A Multicentric Planning Study Based on a Reference Dataset of Patients
The cost of particle therapy (PT) are considerably higher than conventional radiotherapy (RT) with photons. Considering potential dosimetric advantages of PT, it is necessary to determine if PT are more cost-effective than photons per indication regarding quality of life, survival, and progression free survival. Given the lack of evidence for the benefit of particle therapy in relevant cases, investigators proposed an in silico trial to investigate to what extend proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. Given validated dose-response curves and/or NTCP models, a 10% lower mean dose of proton therapy on normal tissue compared to photon therapy should result in at least a 20% lower risk of side effects.
Read the detailed description
Patients with low grade glioma have a far better prognosis than patients with high grade glioma. Despite their low incidence and initial favorable biological behavior, low-grade gliomas are behaving as malignant brain tumours leading to considerable morbidity and mortality especially in young patients. Low-grade infiltrating gliomas in adults include diffuse astrocytoma, oligoastrocytoma and oligodendroglioma. With the WHO 2007 classification the variety within the low grade glioma patient group was large. With the introduction of molecular marker like IDH, MGMT, 1p/19q the classification of glioma's in general is a matter of debate, because shifts in treatments and prognosis. In this context, the importance of molecular markers is recognized and used for designing new trials.
Because of this improved determining of long term survivors like low grade glioma patients, reducing the long term side effect becomes even more relevant. One of the prominent side effect of radiotherapy in low grade glioma patients is the decline in neurocognitive function and loss of memory. This enables patients in their daily activities and causes loss of quality of life. The hippocampus and associated limbic system have long been known to be important in memory formation and pre-clinical models show loss of hippocampal stem cells with radiation as well as changes in architecture and function of mature neurons. Cognitive outcomes in clinical studies are beginning to provide evidence of cognitive effects associated with hippocampal dose and the cognitive benefits of hippocampal sparing. With currently developing IMRT techniques attempts are made to lower the dose to the hippocampus. Besides the hippocampus the dose to the posterior part of the cerebellum seems to influence cognition. Koziol wrote recently the current consensus paper which gathers diverse views on a variety of important roles played by the cerebellum across a range of cognitive and emotional functions. This paper considers the cerebellum in relation to neurocognitive development, language function, working memory, executive function, and the development of cerebellar internal control models and reflects upon some of the ways in which better understanding the cerebellum's status as a "supervised learning machine" can enrich our ability to understand human function and adaptation.
This in silico planning study compares different treatments (photon, proton and C-ion) focusing on normal tissue radiation exposure for a fixed tumor dose, using the same delineation of gross target volume (GTV), clinical target volume (CTV) and planning target volume (PTV). The comparison will be based on dosimetric parameters on normal tissues such as mean hippocampus dose, etc. In addition, the NTCP for a fixed tumor dose or the same expected TCP will be determined. Cobalt Gy equivalent doses will be used when reporting the proton and C-ion dose. In the case of protons, a constant RBE value of 1.1 will be used for both the tumor and the normal tissues. The RBE of C-ions will be calculated based on the models used by the participating centers. The GSI in-house treatment planning system uses RBE values calculated on the basis of the local effect model (LEM). The LEM I (alpha/beta=2) is based on the radial dose distribution of each charged particle crossing into a cell nucleus, as well as on the radiosensitivity and repair capacity of the tissue. The TPSs used by UHM is also based on the LEM model. The model used at NIRS utilizes fixed RBE values that are dependent on the depth in the body, but independent of dose level or tumor type.
- Conditions
- Low Grade Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Dmean
The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmean
Measured: 1 month
Dmax
The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmax
Measured: 1 month
Secondary outcomes (1)
Normal Tissue Complication Probability
Based on the OAR's radiation exposure, normal tissue complication probability (NTCP) will be calculated using existing models or existing dose response curves.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade GliomaStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Nijmegen, Radiotherapy Group Deventer, Heidelberg University, University of Giessen
- Responsible party
- Sponsor
- Investigators
- Philippe Lambin, MD, PhD, Principal investigator, Maastro Clinic, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607397
- Sponsor's protocol ID
- ROCOCO LGG
- Acronym
- ROCOCO LGG
- Status last verified
- Mar 2017
- First submitted
- 12 Nov 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Silico Clinical Trial on Irradiation Low Grade Glioma, Comparing Photon and Proton Therapy: A Multicentric Planning Study Based on a Reference Dataset of Patients
- ClinicalTrials.gov ID
- NCT02607397
- Acronym / sponsor ID
- ROCOCO LGG / ROCOCO LGG
- Conditions
- Low Grade Glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- University Medical Center Nijmegen, Radiotherapy Group Deventer, Heidelberg University, University of Giessen
- Study start
- May 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Nov 2015 (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 cost of particle therapy (PT) are considerably higher than conventional radiotherapy (RT) with photons. Considering potential dosimetric advantages of PT, it is necessary to determine if PT are more cost-effective than photons per indication regarding quality of life, survival, and progression free survival. Given the lack of evidence for the benefit of particle therapy in relevant cases, investigators proposed an in silico trial to investigate to what extend proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. Given validated dose-response curves and/or NTCP models, a 10% lower mean dose of proton therapy on normal tissue compared to photon therapy should result in at least a 20% lower risk of side effects.
Detailed description
Patients with low grade glioma have a far better prognosis than patients with high grade glioma. Despite their low incidence and initial favorable biological behavior, low-grade gliomas are behaving as malignant brain tumours leading to considerable morbidity and mortality especially in young patients. Low-grade infiltrating gliomas in adults include diffuse astrocytoma, oligoastrocytoma and oligodendroglioma. With the WHO 2007 classification the variety within the low grade glioma patient group was large. With the introduction of molecular marker like IDH, MGMT, 1p/19q the classification of glioma's in general is a matter of debate, because shifts in treatments and prognosis. In this context, the importance of molecular markers is recognized and used for designing new trials.
Because of this improved determining of long term survivors like low grade glioma patients, reducing the long term side effect becomes even more relevant. One of the prominent side effect of radiotherapy in low grade glioma patients is the decline in neurocognitive function and loss of memory. This enables patients in their daily activities and causes loss of quality of life. The hippocampus and associated limbic system have long been known to be important in memory formation and pre-clinical models show loss of hippocampal stem cells with radiation as well as changes in architecture and function of mature neurons. Cognitive outcomes in clinical studies are beginning to provide evidence of cognitive effects associated with hippocampal dose and the cognitive benefits of hippocampal sparing. With currently developing IMRT techniques attempts are made to lower the dose to the hippocampus. Besides the hippocampus the dose to the posterior part of the cerebellum seems to influence cognition. Koziol wrote recently the current consensus paper which gathers diverse views on a variety of important roles played by the cerebellum across a range of cognitive and emotional functions. This paper considers the cerebellum in relation to neurocognitive development, language function, working memory, executive function, and the development of cerebellar internal control models and reflects upon some of the ways in which better understanding the cerebellum's status as a "supervised learning machine" can enrich our ability to understand human function and adaptation.
This in silico planning study compares different treatments (photon, proton and C-ion) focusing on normal tissue radiation exposure for a fixed tumor dose, using the same delineation of gross target volume (GTV), clinical target volume (CTV) and planning target volume (PTV). The comparison will be based on dosimetric parameters on normal tissues such as mean hippocampus dose, etc. In addition, the NTCP for a fixed tumor dose or the same expected TCP will be determined. Cobalt Gy equivalent doses will be used when reporting the proton and C-ion dose. In the case of protons, a constant RBE value of 1.1 will be used for both the tumor and the normal tissues. The RBE of C-ions will be calculated based on the models used by the participating centers. The GSI in-house treatment planning system uses RBE values calculated on the basis of the local effect model (LEM). The LEM I (alpha/beta=2) is based on the radial dose distribution of each charged particle crossing into a cell nucleus, as well as on the radiosensitivity and repair capacity of the tissue. The TPSs used by UHM is also based on the LEM model. The model used at NIRS utilizes fixed RBE values that are dependent on the depth in the body, but independent of dose level or tumor type.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 patients. Each patient will function as his or her own control.
Key inclusion criteria (2 listed)
- Low Grade Glioma patients
- Treated with radical intent
Key exclusion criteria (1 listed)
- No Low Grade Glioma
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
Dmean
Time frame: 1 month
The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmean
Dmax
Time frame: 1 month
The normal tissue dose volume parameters per tumor type are defined as Hippocampus: Dmax
1 secondary outcome
Normal Tissue Complication Probability
Time frame: 1 month
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 28 Mar 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.
Philippe Lambin, MD, PhD principal investigator
Maastro Clinic, The Netherlands
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Grade Glioma, run by Maastricht Radiation Oncology at 4 sites in 2 countries.
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 2 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, 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?
Dmean (time frame: 1 month). The study lists 2 primary outcomes in all. 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 28 Mar 2017.