Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535997
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Descriptive Cohort of French Patients Treated With Carbonetherapy Since October 2010 Outside PHRC-ETOILE - PRIMHADRON
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMHADRON
Brief Summary:
Since the 1990s carbonetherapy radiotherapy has been developed in a few sites around the world mainly to treat inoperable and highly radioresistant tumors In the absence of a treatment center of this type in France the French health insurance system and health authorities DGOS INCa and HAS have contributed to the setting up of a prospective randomized controlled study PHRC-ETOILE to evaluate this practice and have also authorized on the basis of expert opinion treatment outside the PHRC of patients who could not be included in the PHRC but whose indications were very similar to those mentioned in the PHRC
This out-of-study cohort began in October 2010 and has continued to grow steadily By the end of 2022 it had reached 53 patients
It is important to study the impact of carbonetherapy on these patients in order to gain an initial appreciation of the benefits tolerability and contribution of this practice for patients
Local control progression-free survival and overall survival in this cohort will be studied as well as the role of carbon therapy in the management of these patients some of whom are very complex Complications attributable to carbon therapy care pathways and changes in patients quality of life will also be analyzed
This analysis will make a contribution to the overall evaluation of carbonetherapy assessing its usefulness and therefore the benefit to patients of its application In our future prospects some of these cases around 23 could be used to consolidate the PHRC-ETOILE cohort
This study will contribute to the development of the case for carbonetherapy enabling the health authorities to make an informed decision on whether or not to expand access to this therapy
PHRC-ETOILE First Transnational Randomized Prospective Trial Comparing Carbon Therapy versus Non-Carbon Therapy for Radioresistant Tumors
PHRC Hospital clinical research programme
This out-of-study cohort began in October 2010 and has continued to grow steadily By the end of 2022 it had reached 53 patients
It is important to study the impact of carbonetherapy on these patients in order to gain an initial appreciation of the benefits tolerability and contribution of this practice for patients
Local control progression-free survival and overall survival in this cohort will be studied as well as the role of carbon therapy in the management of these patients some of whom are very complex Complications attributable to carbon therapy care pathways and changes in patients quality of life will also be analyzed
This analysis will make a contribution to the overall evaluation of carbonetherapy assessing its usefulness and therefore the benefit to patients of its application In our future prospects some of these cases around 23 could be used to consolidate the PHRC-ETOILE cohort
This study will contribute to the development of the case for carbonetherapy enabling the health authorities to make an informed decision on whether or not to expand access to this therapy
PHRC-ETOILE First Transnational Randomized Prospective Trial Comparing Carbon Therapy versus Non-Carbon Therapy for Radioresistant Tumors
PHRC Hospital clinical research programme
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None