Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361043
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-03-25
Brief Title:
Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer ARTEC
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer ARTEC
Status:
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:
ARTEC
Brief Summary:
Despite multimodal therapy patients with esophageal cancer have poor prognosis with 5-year overall survival around 25 Considering tumor-related death as main reason for high mortality rate in those patients treatment-related cardio-pulmonary toxicities could also play a role in this regard Online adaptive radiotherapy offers the possibility for daily re-planning and therefore helps radiation oncologists to better spare the organs at risk and reduce radiation-induced toxicity Tha aim of ARTEC is to assess the pulmonary toxicity in patients with esophageal cancer treated with online adaptive radiotherapy
Detailed Description:
Esophageal cancer EC is currently the tenth most common cancer and sixth leading cause of cancer-related mortality worldwide Multimodal treatment strategy consisting of surgery with pre-perioperative Radio-chemotherapy RCHT regimens the standard of care for non-metastatic locally advanced EC However the treatment of EC is challenging and the risk of tumor recurrence remains high Furthermore toxicities of such combined treatments can be substantial and there is room for optimization of RT to reduce the radiation dose to heart and lungs While 3D-conformal radiotherapy is traditionally used for treatment of EC modern irradiation techniques such as intensity-modulated radiotherapy IMRT or volumetric intensity modulated arc therapy VMAT are increasingly implemented in the management of EC The investigators know from literature that esophageal motion could be a challenge and therefore bigger margins are needed to achieve an acceptable tumor coverage In addition to positioning and motion uncertainties there could be a substantial inter-fractional tumor size reduction during RCHT Tumor shrinkage can consequently lead to OARs shifting into the target volumes which results in excess radiation dose to OARs with increased toxicity Adaptive radiotherapy ART is a treatment technique to do a re-planning during the course of treatment to adjust the delivery of radiation dose based on geometrical changes of tumor and OARs Considering the uncertainties in OAR and tumor displacement positioning as well as tumor size reduction during RCHT makes EC a perfect candidate for ART This single-arm prospective study aims to assess pulmonary toxicity and dosimetrical analysis of ART for EC
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