Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538337
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hypofractionated External Beam Radiotherapy With Adaptive Planning for Endometrial and Cervical Cancers HERA Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
HERA
Brief Summary:
After surgery to remove the main endometrial andor cervical tumor most women receive radiation therapy This study uses hypo-fractionated radiation therapy which is a type of radiation therapy in which the total prescribed dose of radiation is delivered in fewer but larger doses than conventional or standard radiotherapy
This research study aims to determine if hypo-fractionated radiation therapy given after surgery can improve treatment tolerability ie fewer treatments with comparable side effects
Participants will be in the study for about 5 years
Radiation therapy
5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy SBRT
Each treatment session will occur on a weekday typically consecutive weekdays and will last approximately an hour
Treatment Follow-Up
Check-up Appointment and answer questions at 3 months post RT
Check-up Appointments with physical exam every 6 months - 4 weeks for up to 5 years
This research study aims to determine if hypo-fractionated radiation therapy given after surgery can improve treatment tolerability ie fewer treatments with comparable side effects
Participants will be in the study for about 5 years
Radiation therapy
5 daily treatment sessions of MRI or CT-Guided Stereotactic Body Radiation Therapy SBRT
Each treatment session will occur on a weekday typically consecutive weekdays and will last approximately an hour
Treatment Follow-Up
Check-up Appointment and answer questions at 3 months post RT
Check-up Appointments with physical exam every 6 months - 4 weeks for up to 5 years
Detailed Description:
The investigators hypothesize that adaptive planning with either computed tomography CT or magnetic resonance imaging MRI guidance may offer improved SBRT plans for postoperative gynecological cancer patients due to issues with anatomic variation between and during fractions of radiation therapy Treatment on an MRI-guided linear accelerator with adaptive planning capabilities has been shown to significantly improve acute toxicity in the setting of prostate SBRT compared to conventional linear accelerators10 The investigators therefore propose using adaptive planning with CT- or MRI-guidance to deliver 30 Gy in 5 fraction adjuvant SBRT to the pelvis for endometrial and cervical cancer patients
Stereotactic Body Radiation Therapy SBRT with adaptive planning will be delivered following surgical resection of the primary tumor Patients will receive 60 Gy x 5 fractions delivered once every other day Patients will not be treated on weekends or holidays as is standard practice for radiation treatments
Patients will be seen by the radiation oncologist within the first 3 months after completion of radiation therapy For patients who live a distance far enough away from the University of California at Los Angeles UCLA where travel would be challenging for the patient a phone or telemedicine follow-up will be considered acceptable After this follow-up will be performed every 6 months - 4 weeks for 5 years following completion of radiotherapy Patients will be followed clinically andor radiographically per physician discretion
SCHEMA
Diagnosis of endometrial or cervical cancer
Surgical resection of primary tumor
Multidisciplinary discussion and recommendation for adjuvant radiotherapy to the pelvis
Patient enrollment in HERA clinical trial
Simulation scans to plan post-operative radiotherapy
Five fractions of radiation therapy using adaptive planning and CT or MRI guidance 6 Gy per fraction delivered once every other day excluding weekends and holidays
Follow-up within 3 months of completion of radiotherapy
Follow-up every 6 months - 4 weeks until 5 years of completion of radiotherapy
Stereotactic Body Radiation Therapy SBRT with adaptive planning will be delivered following surgical resection of the primary tumor Patients will receive 60 Gy x 5 fractions delivered once every other day Patients will not be treated on weekends or holidays as is standard practice for radiation treatments
Patients will be seen by the radiation oncologist within the first 3 months after completion of radiation therapy For patients who live a distance far enough away from the University of California at Los Angeles UCLA where travel would be challenging for the patient a phone or telemedicine follow-up will be considered acceptable After this follow-up will be performed every 6 months - 4 weeks for 5 years following completion of radiotherapy Patients will be followed clinically andor radiographically per physician discretion
SCHEMA
Diagnosis of endometrial or cervical cancer
Surgical resection of primary tumor
Multidisciplinary discussion and recommendation for adjuvant radiotherapy to the pelvis
Patient enrollment in HERA clinical trial
Simulation scans to plan post-operative radiotherapy
Five fractions of radiation therapy using adaptive planning and CT or MRI guidance 6 Gy per fraction delivered once every other day excluding weekends and holidays
Follow-up within 3 months of completion of radiotherapy
Follow-up every 6 months - 4 weeks until 5 years of completion of radiotherapy
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