Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978024
Status:
RECRUITING
Last Update Posted:
2023-08-07
First Post:
2023-07-14
Brief Title:
Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities - Cohort B
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
Official Title:
Predicting Radiotherapy Response Toxicities and Quality of Life Related Functional Outcome in Soft Tissue Sarcoma of the Extremities a Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-07
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:
PredicT-B
Brief Summary:
This is a multicentre prospective cohort study primarily aimed at reporting the frequency and intensity of radiotherapy side-effects of patients with soft tissues sarcoma of the extremities STSE
Two sub-studies are proposed within this study
MRI radiation response assessment Aimed at establishing whether changes in median apparent diffusion coefficients ADC are predictive of pre-operative STSE response measured using histopathology
Biomarker development and Immune mediators associated with radiotherapy Aimed at establishing prognostic markers which may refine selection of cases for pre-operative palliative or no radiotherapy
Also aimed at determining if radiotherapy stimulates the tumour microenvironment resulting in measurable change in anti-tumour immunity and if certain subtypes could potentially benefit from the addition of immunotherapy with radiation
Patients participation in the sub-studies is optional
Two sub-studies are proposed within this study
MRI radiation response assessment Aimed at establishing whether changes in median apparent diffusion coefficients ADC are predictive of pre-operative STSE response measured using histopathology
Biomarker development and Immune mediators associated with radiotherapy Aimed at establishing prognostic markers which may refine selection of cases for pre-operative palliative or no radiotherapy
Also aimed at determining if radiotherapy stimulates the tumour microenvironment resulting in measurable change in anti-tumour immunity and if certain subtypes could potentially benefit from the addition of immunotherapy with radiation
Patients participation in the sub-studies is optional
Detailed Description:
This is a multicentre prospective cohort study primarily aimed at validating the dose-volume parameters identified in the analyses of the VorteX and IMRiS trials datasets
Delineation of healthy tissues
Pre-defined outlining guidelines of normal tissues as bones muscle compartments joints lymph drainage basins and subcutaneous tissue from Predict A will be delineated in radiotherapy planning computed tomography CT images All cases will be delineated by a single observer Rita Simoes Verification of all outlines will be carried out by Dr Aisha Miah clinical supervisor
Dose-volume constraints validity testing
Patients will be treated as per local protocol treatment technique
Radiotherapy clinical and toxicities data will be collected with no new intervention on the treatment Patients enrolled will receive standard radiation prescription doses as described below
Pre-operative radiotherapy- 50 Gy in 25 fractions equivalent pre-operative radiotherapy Where appropriate hypo-fractionated schedules as per institutional guidelines can considered eg 25 Gy 5 daily fractions In myxoid liposarcomas 36 Gy in 18 fractions can be considered where suitable
Post-operative radiotherapy- 60 Gy in 30 fractions or 66 Gy in 33 fractions positive resection margins alternative hypo-fractionated schedules as per institutional guidelines can be considered
Palliative radiotherapy- 30-36 Gy in 10-12 daily fractions 40-45 Gy in 15 fractions 30-36 Gy in 5-6 once weekly fractions or 25 Gy in 5 daily fractions
Toxicity will be assessed with the TESS and RTOG scoring instruments and Stern score for lymphoedema Patients enrolled in the study will fill in a specific quality-of-life questionnaire to assess quality of life related functional outcomes following treatment for STSE This questionnaire is based on validated questions for assessing quality-of-life Patients will be followed up at 3 6 12 18 and 24 months post-radiotherapy
Delineation of healthy tissues
Pre-defined outlining guidelines of normal tissues as bones muscle compartments joints lymph drainage basins and subcutaneous tissue from Predict A will be delineated in radiotherapy planning computed tomography CT images All cases will be delineated by a single observer Rita Simoes Verification of all outlines will be carried out by Dr Aisha Miah clinical supervisor
Dose-volume constraints validity testing
Patients will be treated as per local protocol treatment technique
Radiotherapy clinical and toxicities data will be collected with no new intervention on the treatment Patients enrolled will receive standard radiation prescription doses as described below
Pre-operative radiotherapy- 50 Gy in 25 fractions equivalent pre-operative radiotherapy Where appropriate hypo-fractionated schedules as per institutional guidelines can considered eg 25 Gy 5 daily fractions In myxoid liposarcomas 36 Gy in 18 fractions can be considered where suitable
Post-operative radiotherapy- 60 Gy in 30 fractions or 66 Gy in 33 fractions positive resection margins alternative hypo-fractionated schedules as per institutional guidelines can be considered
Palliative radiotherapy- 30-36 Gy in 10-12 daily fractions 40-45 Gy in 15 fractions 30-36 Gy in 5-6 once weekly fractions or 25 Gy in 5 daily fractions
Toxicity will be assessed with the TESS and RTOG scoring instruments and Stern score for lymphoedema Patients enrolled in the study will fill in a specific quality-of-life questionnaire to assess quality of life related functional outcomes following treatment for STSE This questionnaire is based on validated questions for assessing quality-of-life Patients will be followed up at 3 6 12 18 and 24 months post-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