Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452485
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-03
Brief Title:
Postoperative Re-irradiaTion With and Without HYPERthermia Toxicity Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Postoperative Re-irradiaTion With and Without HYPERthermia Toxicity Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
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:
RT-HYPE
Brief Summary:
In the Netherlands breast cancer patients with locoregional recurrence LRR and high-risk factors are treated with postoperative re-irradiation with or without hyperthermia Retrospective studies showed that 3-year locoregional control after postoperative re-irradiation with hyperthermia was 68-83 and severe toxicity in up to 40 of LRR patients Unfortunately no prospective randomized data are available on clinical outcomes Consequently variation exists in hyperthermia-treatment and re-irradiation schedules Prospective real-world data on oncological outcomes toxicity and quality of life is highly needed for shared decision-making between patients and professionals These data will be used in the design of a future randomized trial comparing postoperative re-irradiation and hyperthermia-treatment in high-risk LRR patients
Detailed Description:
The optimal management of LRR breast cancer is multidisciplinary and based on various prognostic risk factors and previous treatments The surgical treatment of local recurrences is salvage mastectomy after previous breast-conserving therapy or local excision after previous mastectomy Regional treatment of tumor-positive lymph nodes consists of axillary radiotherapy andor lymph node dissection High-risk LRR patients have an indication for postoperative irradiation to improve locoregional control and disease-free survival In previously irradiated high-risk LRR patients postoperative re-irradiation is administered with or without hyperthermia in the Netherlands depending on the treating center and treating professional Before the preoperative systemic treatment era primary re-irradiation with hyperthermia was the evidence-based standard of care in high-risk unresectable LRR Hyperthermia was used to increase the therapeutic efficacy of re-irradiation The introduction of preoperative systemic therapy in 2010 resulted in more resectable high-risk LRRs This resulted in postoperative re-irradiation instead of primary re-irradiation in LRR patients including variation in the use of hyperthermia There is no evidence-based standard of care regarding the combination of postoperative re-irradiation with or without hyperthermia in high-risk LRR patients The major problem is that only retrospective data and no prospective randomized data is available on oncological outcomes survival and recurrence and toxicity following postoperative re-irradiation and hyperthermia Consequently there is a high need to assess oncological outcomes and toxicity of postoperative re-irradiation with or without hyperthermia in a randomized controlled trial RCT So far an RCT has not been feasible due to the large variation in postoperative re-irradiation and hyperthermia and preferences regarding hyperthermia-treatment by professionals In the RT-HYPE study the investigators evaluate oncological outcomes toxicity and quality of life in high-risk LRR patients including the harmonization of hyperthermia-treatment The results of the RT-HYPE study are needed for the optimization of the shared decision making SDM process on post-operative re-irradiation with or without hyperthermia between professionals and patients In addition these results allow to set-up a future RCT comparing postoperative re-irradiation with and without hyperthermia treatment
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