Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142760
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-11-15
Brief Title:
MR-guidance in Chemoradiotherapy for Cervical Cancer
Sponsor:
Juergen Debus
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Daily AI-based Treatment Adaptation Under Weekly Offline MR-guidance in Chemoradiotherapy for Cervical Cancer 1 AIM-C1
Status:
RECRUITING
Status Verified Date:
2024-01
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:
AIM-C1
Brief Summary:
Concurrent chemoradiotherapy CCRT consisting of external beam radiotherapy EBRT and chemotherapy followed by brachytherapy BT is the standard of care for patients with locally advanced cervical carcinoma In current clinical practice conventionally one radiotherapy plan based on the initial planning computed tomography CT and magnetic resonance imaging MRI scan of the pelvis is applied for the complete 5-6 weeks of EBRT However there is a high degree of cervix and uterus motion in the pelvis due to different fillings of the bladder and the bowel Consequently large safety margins are required to compensate for organ movement potentially leading to higher toxicity Lately daily high-quality cone-beam CT CBCT guided adaptive radiotherapy aided by artificial intelligence AI became clinically available Due to the improved soft-tissue contrast the treatment plan can now be online adapted to the current position of the tumor and the adjacent organs-at-risk OAR while the patient is lying on the treatment couch Moreover the German Research Cancer Center offers the unique possibility of additional weekly magnetic resonance imaging MRI in treatment position using a shuttle system Daily CBCT-adapted EBRT in combination with weekly MRI in treatment position might therefore offer superior sparing of surrounding OAR and consequently reduction of treatment-associated side-effects
However to the investigators knowledge no toxicity data for daily CBCTAI adaptive EBRT of locally advanced cervical cancer with additional MR-guidance exists The AIM-C1 trial therefore aims to assess the potential of daily CBCT adaptive and AI aided EBRT combined with additional weekly offline MR-guidance in treatment position using a shuttle system
However to the investigators knowledge no toxicity data for daily CBCTAI adaptive EBRT of locally advanced cervical cancer with additional MR-guidance exists The AIM-C1 trial therefore aims to assess the potential of daily CBCT adaptive and AI aided EBRT combined with additional weekly offline MR-guidance in treatment position using a shuttle system
Detailed Description:
This trial will be conducted as a prospective one-armed phase II study in 40 patients with cervical carcinoma FIGO stage IB IIA IIB IIIA IIIB IIIC1 age 18 years Karnofsky Performance Score 70 CCRT will consist of 504Gy external beam radiotherapy EBRT with concurrent cisplatin 40mgm² as standard of care in Germany followed by 27Gy of BT in 4 fractions of 7Gy
The primary endpoint of the trial will be the occurrence of overall early bowel and bladder toxicity CTCAE grade 2 or higher assessed within the first 3 months with NCI CTCAE Version 50
Secondary outcomes to be investigated are clinical feasibility of daily CBCT-guided and weekly MR-guided plan adaptation local tumor control distant tumor control progression-free survival overall survival quality of life acquisition and comparison of different MRI sequences technical analyses of treatment adaptation frequency and morphological as well as functional tumor characteristics of the MRI
The primary endpoint of the trial will be the occurrence of overall early bowel and bladder toxicity CTCAE grade 2 or higher assessed within the first 3 months with NCI CTCAE Version 50
Secondary outcomes to be investigated are clinical feasibility of daily CBCT-guided and weekly MR-guided plan adaptation local tumor control distant tumor control progression-free survival overall survival quality of life acquisition and comparison of different MRI sequences technical analyses of treatment adaptation frequency and morphological as well as functional tumor characteristics of the MRI
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