Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06029140
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2023-08-01
Brief Title:
Stereotactic Radiotherapy Management of Brain Metastases the Value of a Longitudinal Multimodal Approach POSTPONE
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Stereotactic Radiotherapy Management of Brain Metastases the Value of a Longitudinal Multimodal Approach
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSTPONE
Brief Summary:
The management of brain metastases has evolved rapidly in recent years It is estimated that 20 to 40 of cancer patients will develop brain metastases BM during the course of their disease Whole-brain radiotherapy has long been the first-line treatment for brain metastases However large-scale international clinical trials conducted over the past decade have established stereotactic radiotherapy SR as the treatment of choice for the management of brain metastases BM However even though the method of radiation delivery has evolved considerably the problem of monitoring and managing brain metastases remains unresolved
This study therefore has several focuses
1 Evaluation of the benefit of early remnographic assessment 6 weeks impact on recurrence-free survival and overall survival
2 Evaluation of a diagnostic approach to radionecrosis complementarity of DOPA PET and multimodal MRI
3 The benefits of longitudinal remnographic monitoring with the development of segmentation and automated follow-up tools
This study therefore has several focuses
1 Evaluation of the benefit of early remnographic assessment 6 weeks impact on recurrence-free survival and overall survival
2 Evaluation of a diagnostic approach to radionecrosis complementarity of DOPA PET and multimodal MRI
3 The benefits of longitudinal remnographic monitoring with the development of segmentation and automated follow-up tools
Detailed Description:
The management of brain metastases has evolved rapidly in recent years It is estimated that 20 to 40 of cancer patients will develop brain metastases BM during the course of their disease Whole-brain radiotherapy has long been the first-line treatment for brain metastases However large-scale international clinical trials conducted over the past decade have established stereotactic radiotherapy SRT as the treatment of choice for the management of brain metastases BM However even though the method of radiation delivery has evolved considerably the problem of monitoring and managing brain metastases remains unresolved Indeed BM patients constitute a growing population due to the increased efficacy of systemic treatments making the occurrence of BM higher Management of the disease is not only aimed at alleviating symptoms and initially improving survival but must also take into account patients quality of life Patients with a poor prognosis should not be over-treated while those with a more favorable prognosis should not be under-treated
With this in mind a number of tools were rapidly developed to grade the prognosis of patients with BM Recursive partitioning analysis RPA and Graded Prognostic Assessment GPA are the main ones They are based on prognostic factors that include age Karnofsky index primary tumor control presence of extracerebral localization histological type and presence of genetic mutations for each primary Finally we must also take into account the growing involvement of systemic treatments in the control of brain disease when the blood-brain barrier BBB is crossed
Several studies have shown that patients with symptomatic cerebral recurrences have poorer survival and generate higher costs for the healthcare system than asymptomatic patients whose recurrences have been detected by routine surveillance imaging The importance of frequent surveillance imaging is therefore essential National Comprehensive Cancer Network NCCN recommendations include MRI every 2-3 months for the first year then every 4-6 months indefinitely The recommendations of the Association des Neuro-Oncologues dExpression Française ANOCEF recommend brain MRI at least every 3 months for the first year 9 RECORAD recommends MRI surveillance every 3 months for the first 2 years then every 6 months 10 and Cancer Care Ontario Organization CCO recommends a 1st follow-up MRI 2 to 3 months after the end of treatment followed by MRI surveillance every 2 to 3 months for 1 year and MRI surveillance every 3 to 4 months for 2 to 3 years Given the heterogeneity of follow-up modalities and the absence of any recommendation for surveillance MRI imaging earlier than 3 months after treatment the Brest University Hospital decided to carry out an early remnographic reassessment of patients treated with intracerebral stereotactic radiotherapy 6 weeks after the end of treatment and then every 3 months for a minimum of 2 years
After SRT for brain metastases the median time to development of a radiation-induced adverse event or radionecrosis is 7 to 11 months Similarly the risk of local tumor recurrence after SR is 5 after 18 months In terms of complications improvements in systemic therapy mean that patients are living longer and are at greater risk of tumour recurrence later than previously defined as 18 months after SRT Radionecrosis may therefore occur in up to 50 of patients several months to several years after irradiation depending on several factors including dose fractionation patterns and the volume of normal brain receiving high-dose irradiation
Radionecrosis can produce symptoms difficult to distinguish from those of local progression and if left untreated can lead to significant morbidity and mortality Correct differential diagnosis between radionecrosis and local progression is extremely important as the two situations must be managed differently Surgery or re-irradiation is generally proposed as salvage therapy in patients with local progression whereas radionecrosis is most often treated with corticosteroids
Differential diagnosis between radiation-induced changes and brain tumor recurrence is a challenge in the treatment of brain metastases The RANO Response Assessment in Neuro-Oncology group has recognized that an approach based on a single imaging modality is insufficient to establish a correct diagnosis It recommends the use of advanced imaging techniques such as MRI with diffusion sequence and perfusion map spectroscopy and PET
Several radiopharmaceuticals including the amino acid tracers O-2-18Ffluoroethyl-L-tyrosine FET and 34-dihydroxy-6-18F-fluoro- l-phenylalanine F-DOPA have proved useful in distinguishing radionecrosis from local progression in patients with brain metastases
Several observations can therefore be made
Heterogeneity of practices concerning remnographic surveillance particularly at an early stage
Heterogeneity in practices concerning suspicion of radionecrosis
This study therefore has several focuses
1 Evaluation of the benefit of early remnographic assessment 6 weeks impact on recurrence-free survival and overall survival
2 Evaluation of a diagnostic approach to radionecrosis complementarity of DOPA PET and multimodal MRI
3 The benefits of longitudinal remnographic monitoring with the development of segmentation and automated follow-up tools
With this in mind a number of tools were rapidly developed to grade the prognosis of patients with BM Recursive partitioning analysis RPA and Graded Prognostic Assessment GPA are the main ones They are based on prognostic factors that include age Karnofsky index primary tumor control presence of extracerebral localization histological type and presence of genetic mutations for each primary Finally we must also take into account the growing involvement of systemic treatments in the control of brain disease when the blood-brain barrier BBB is crossed
Several studies have shown that patients with symptomatic cerebral recurrences have poorer survival and generate higher costs for the healthcare system than asymptomatic patients whose recurrences have been detected by routine surveillance imaging The importance of frequent surveillance imaging is therefore essential National Comprehensive Cancer Network NCCN recommendations include MRI every 2-3 months for the first year then every 4-6 months indefinitely The recommendations of the Association des Neuro-Oncologues dExpression Française ANOCEF recommend brain MRI at least every 3 months for the first year 9 RECORAD recommends MRI surveillance every 3 months for the first 2 years then every 6 months 10 and Cancer Care Ontario Organization CCO recommends a 1st follow-up MRI 2 to 3 months after the end of treatment followed by MRI surveillance every 2 to 3 months for 1 year and MRI surveillance every 3 to 4 months for 2 to 3 years Given the heterogeneity of follow-up modalities and the absence of any recommendation for surveillance MRI imaging earlier than 3 months after treatment the Brest University Hospital decided to carry out an early remnographic reassessment of patients treated with intracerebral stereotactic radiotherapy 6 weeks after the end of treatment and then every 3 months for a minimum of 2 years
After SRT for brain metastases the median time to development of a radiation-induced adverse event or radionecrosis is 7 to 11 months Similarly the risk of local tumor recurrence after SR is 5 after 18 months In terms of complications improvements in systemic therapy mean that patients are living longer and are at greater risk of tumour recurrence later than previously defined as 18 months after SRT Radionecrosis may therefore occur in up to 50 of patients several months to several years after irradiation depending on several factors including dose fractionation patterns and the volume of normal brain receiving high-dose irradiation
Radionecrosis can produce symptoms difficult to distinguish from those of local progression and if left untreated can lead to significant morbidity and mortality Correct differential diagnosis between radionecrosis and local progression is extremely important as the two situations must be managed differently Surgery or re-irradiation is generally proposed as salvage therapy in patients with local progression whereas radionecrosis is most often treated with corticosteroids
Differential diagnosis between radiation-induced changes and brain tumor recurrence is a challenge in the treatment of brain metastases The RANO Response Assessment in Neuro-Oncology group has recognized that an approach based on a single imaging modality is insufficient to establish a correct diagnosis It recommends the use of advanced imaging techniques such as MRI with diffusion sequence and perfusion map spectroscopy and PET
Several radiopharmaceuticals including the amino acid tracers O-2-18Ffluoroethyl-L-tyrosine FET and 34-dihydroxy-6-18F-fluoro- l-phenylalanine F-DOPA have proved useful in distinguishing radionecrosis from local progression in patients with brain metastases
Several observations can therefore be made
Heterogeneity of practices concerning remnographic surveillance particularly at an early stage
Heterogeneity in practices concerning suspicion of radionecrosis
This study therefore has several focuses
1 Evaluation of the benefit of early remnographic assessment 6 weeks impact on recurrence-free survival and overall survival
2 Evaluation of a diagnostic approach to radionecrosis complementarity of DOPA PET and multimodal MRI
3 The benefits of longitudinal remnographic monitoring with the development of segmentation and automated follow-up tools
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None