Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508703
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2007-07-26
Brief Title:
Intensity Modulated Radiotherapy IMRT for the Pelvis Post-Hysterectomy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Pilot Study of Intensity Modulated Radiotherapy IMRT to Pelvis Post-Hysterectomy With Analysis of Clinical Target Volume Motion and Relation to Position and Volume of Bladder and Rectum During Course of Radiotherapy for Use in Optimization of Margin Size
Status:
COMPLETED
Status Verified Date:
2017-09
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:
None
Brief Summary:
The goal of this clinical research study is to use CT scans to find any changes in position of the vagina and pelvic lymph node areas during the course of IMRT radiation therapy Treatment can then be adjusted in order to spare as much normal tissue as possible during radiation therapy Another goal is to study the side effects of IMRT radiation therapy
Detailed Description:
The standard radiotherapy technique for delivering radiation therapy to the pelvis following a hysterectomy involves a technique which also causes a large amount of normal tissue to receive radiation This can cause both early and late side effects which may be severe The new technique of intensity modulated radiotherapy IMRT has been used to help spare normal tissue especially tissue of the small bowel This is an advanced new technology that delivers the high-dose of radiation to the target area but avoids the normal tissue Using CT scans the target is outlined by the doctors before treatment However sometimes organs in the pelvis move throughout the course of treatment Using CT scans during treatment and re-outlining the target may help to deliver more radiation to the cancer tissues and less to the surrounding normal areas
During the study you will have additional CT scans that will be performed on a special scanner in the radiation treatment room You also will have additional CT scans twice a week during the 5 weeks of radiation treatment The first 12 participants enrolled will receive the standard radiation therapy taking into account the maximum possible movements of the bladder No adjustments will be made according to the results of the additional CT scans The next 12 participants may have their radiation therapy adjusted according to the CT scans in an effort to target less of the normal tissue without missing cancer tissue To reduce movement of your bladder due to different amounts of fluid in your bladder you will be asked to drink 3 glasses of water before treatment and to come for treatment with a full bladder
The volumes of your bladder and rectum will also be studied and any side effects of the treatment will be recorded You will be asked to fill out a short questionnaire about the side effects of your treatment 3 times per week during treatment It should take around 5 minutes to complete the questionnaire
Patients will be followed for at least 2 years Every 3 months for 1 year and 4 months for second year according to usual clinic practice
This is an investigational study IMRT radiation therapy is an approved method of treating some types of cancer However adjusting the radiation treatment according to the movement of the internal organs is investigational Initial CT scans for treatment planning are part of standard treatment Up to 24 participants will take part in this study All will be enrolled at M D Anderson
During the study you will have additional CT scans that will be performed on a special scanner in the radiation treatment room You also will have additional CT scans twice a week during the 5 weeks of radiation treatment The first 12 participants enrolled will receive the standard radiation therapy taking into account the maximum possible movements of the bladder No adjustments will be made according to the results of the additional CT scans The next 12 participants may have their radiation therapy adjusted according to the CT scans in an effort to target less of the normal tissue without missing cancer tissue To reduce movement of your bladder due to different amounts of fluid in your bladder you will be asked to drink 3 glasses of water before treatment and to come for treatment with a full bladder
The volumes of your bladder and rectum will also be studied and any side effects of the treatment will be recorded You will be asked to fill out a short questionnaire about the side effects of your treatment 3 times per week during treatment It should take around 5 minutes to complete the questionnaire
Patients will be followed for at least 2 years Every 3 months for 1 year and 4 months for second year according to usual clinic practice
This is an investigational study IMRT radiation therapy is an approved method of treating some types of cancer However adjusting the radiation treatment according to the movement of the internal organs is investigational Initial CT scans for treatment planning are part of standard treatment Up to 24 participants will take part in this study All will be enrolled at M D Anderson
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