Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650033
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Pelvis ART is a Two Phase Study Looking at Using Adaptive Radiotherapy to Help Reduce Toxicity for Cancer Patients Receiving Radiotherapy to the Pelvic Region Adaptive Radiotherapy is a New Technology That Provides the Ability yo Account for Daily Changes in Anatomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pelvis Adaptive Radiation Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Pelvis ART
Brief Summary:
Pelvis ART is a two phase study looking at using adaptive radiotherapy to help reduce toxicity for cancer patients having radiotherapy in the pelvic region
Adaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced
Phase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented If phase 1 of this study is safe and feasible the study will proceed to phase 2 Phase 2 of the study looks at using adaptive technology to reduce radiation treatment margins The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for patients with cancer in the pelvic area
Adaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced
Phase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented If phase 1 of this study is safe and feasible the study will proceed to phase 2 Phase 2 of the study looks at using adaptive technology to reduce radiation treatment margins The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for patients with cancer in the pelvic area
Detailed Description:
Despite major technological advancements in the delivery of pelvic radiation therapy including the use of dynamic therapy image guidance integrated boosting and stereotactic techniques toxicity from pelvic radiation remains a significant issue impacting on patients quality of life and preventing the delivery of higher and more curative doses of radiation Although evidence showed that adaptive radiotherapy demonstrating promising reduction of acute toxicity the uptake of adaptive radiotherapy remains poor as adaptive radiation therapy is very labour intensive time consuming and usually requires a radiation oncologist RO and Medical Physicist in attendance to reviewmodify target contours These practices of daily multi-disciplinary team MDT in person attendance is not sustainable in the long term Since 2021 Royal North Shore Hospital has been treating patients with cancer in the pelvic with Adaptive Radiation Therapy ART and Radiation Therapists RT at the site have undergone a rigorous University based Advanced Practitioner training programme This study aims to evaluate RT-led ART in a randomised trial to assess the safety and feasibility of ART in a two stage phase 3 randomised controlled trial
If this study can prove safety and feasibility in the first phase it will proceed to the second phase of the study which will look at using adaptive radiotherapy to safely reduce CTV and PTV margins The primary aim of the study will be to measure the difference in combined acute patient reported gastrointestinal GI and genitourinary GU toxicity between ART with margin reduction versus standard radiotherapy Secondary aims will be to look at differences in clinician and patient reported acute and late GI and GU toxicity disease free survival locoregional control location of recurrence the efficiency of ART including time taken per treatment radiation dosimetric differences between the treatment arms and patients perception of ART
If this study can prove safety and feasibility in the first phase it will proceed to the second phase of the study which will look at using adaptive radiotherapy to safely reduce CTV and PTV margins The primary aim of the study will be to measure the difference in combined acute patient reported gastrointestinal GI and genitourinary GU toxicity between ART with margin reduction versus standard radiotherapy Secondary aims will be to look at differences in clinician and patient reported acute and late GI and GU toxicity disease free survival locoregional control location of recurrence the efficiency of ART including time taken per treatment radiation dosimetric differences between the treatment arms and patients perception of ART
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