Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398314
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-17
Brief Title:
Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
Sponsor:
Sykehuset Telemark
Organization:
Sykehuset Telemark
Study Overview
Official Title:
Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
PALLSOFT
Brief Summary:
PALLSOFT is a randomized open-label non-inferiority phase III multicenter national trial that will investigate whether the patient-reported symptomatic effect of palliative radiotherapy delivered in 1-2 fractions is non-inferior to palliative radiotherapy delivered in five fractions in patients with pelvic soft tissue tumors from either gastrointestinal urological or gynecological cancer Health-related quality of life toxicities survival and prognostic and predictive biomarkers will be assessed as secondary and explorative endpoints
Detailed Description:
Studies and clinical practice have proven palliative radiotherapy to provide efficient symptom relief in patients with symptomatic pelvic soft tissue tumors However studies are mainly retrospective are difficult to compare due to a variety of radiotherapy fractionation schedules used and lack data on patient-reported quality of life Consequently no recommended standard of care is established and several schedules are employed with variations in both number of fractions and total radiation dose measured in GrayGy Given the limited life expectancy of palliative patients a short-course radiotherapy schedule would be preferable provided efficient symptom relief and good health-related quality of life
PALLSOFT is a national randomized non-inferiority study that will investigate whether the symptomatic effect of a short-course radiotherapy schedule of 8 Gy x 1-2 is non-inferior to a more prolonged schedule of 5 Gy x 5 The study will include patients with symptomatic pelvic soft tissue tumors from either gastrointestinal urological or gynecological cancer Patients will defined a target symptom from 5 predefined cathegories pain bleeding bowellower urinary tractvaginal dysfunction and change in symptom intensity will be assessed as well as overall toxicities quality of life and survival Prognostic and predictive biomarkers will be explores the latter with particular emphasis on the significance of tumor hypoxia in palliative radiotherapy
PALLSOFT is a national randomized non-inferiority study that will investigate whether the symptomatic effect of a short-course radiotherapy schedule of 8 Gy x 1-2 is non-inferior to a more prolonged schedule of 5 Gy x 5 The study will include patients with symptomatic pelvic soft tissue tumors from either gastrointestinal urological or gynecological cancer Patients will defined a target symptom from 5 predefined cathegories pain bleeding bowellower urinary tractvaginal dysfunction and change in symptom intensity will be assessed as well as overall toxicities quality of life and survival Prognostic and predictive biomarkers will be explores the latter with particular emphasis on the significance of tumor hypoxia in palliative radiotherapy
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