Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384053
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-15
Brief Title:
Skin Cancer and Hyperthermia and Radiotherapy
Sponsor:
Kantonsspital Winterthur KSW
Organization:
Kantonsspital Winterthur KSW
Study Overview
Official Title:
Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm Open-label Randomized Controlled Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
SAHARA
Brief Summary:
The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy RT with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer NMSC
Detailed Description:
The SAHARA Trial is investigating if adding hyperthermia to radiotherapy RT can enhance treatment outcomes by making cancer cells more sensitive to radiation thus requiring lower doses and potentially reducing side effects The trial compares high-dose RT alone with de-escalated RT plus hyperthermia The aim is to demonstrate that the combination is non-inferior to standard RT in treating non-melanoma skin cancer NMSC The trial is designed for elderly people of 65 years or older
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