Sigmoid Colon Organ Motion in Radiotherapy
Primary Purpose
Sigmoid Cancer, Sigmoid Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Adjuvant image-guided radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Sigmoid Cancer focused on measuring Sigmoid colon cancer, Internal organ motion, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Patients with pathologically confirmed sigmoid colon cancer, who have received surgical excision (AR or LAR).
- Anastomosis of the colon must be performed with a surgical stapler, with the staple visible on CT imaging.
Exclusion Criteria:
- Gross recurrent disease (defined as visible mass on CT imaging) in the pelvis.
- Other malignancy within the pelvic cavity.
- Previous surgery to the pelvic cavity other than AR/LAR.
- Pregnant or lactating females.
- Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adjuvant image-guided radiotherapy
Arm Description
Adjuvant radiotherapy with image guidance via cone beam computed tomography. Treatment is identical to the current standard of care.
Outcomes
Primary Outcome Measures
Interfraction sigmoid colon organ motion
Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) compared to simulation CT
Secondary Outcome Measures
Intrafraction sigmoid colon organ motion
Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) between pre-treatment cone beam computed tomography (CBCT) and post-treatment CBCT
Setup errors
Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT
Full Information
NCT ID
NCT03259828
First Posted
August 21, 2017
Last Updated
February 4, 2021
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03259828
Brief Title
Sigmoid Colon Organ Motion in Radiotherapy
Official Title
Interfraction and Intrafraction Organ Motion of the Sigmoid Colon in Patients With Colorectal Cancer Undergoing Adjuvant Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Radiotherapy is used in cancer treatment to eradicate microscopic cancer cells to lower the risk of recurrence. The radiotherapy plan must account for organ movement inside the body to ascertain adequate dose is delivered to the target. Knowledge of the magnitude is crucial to radiotherapy treatment planning. This study aims to quantify the movement of the sigmoid colon between different fractions of radiotherapy treatment (interfraction motion) and within the same fraction (intrafraction motion). This knowledge will help us determine the optimal margin to use in radiotherapy treatment planning.
Detailed Description
Day-to-day positioning variations contribute to uncertainty in radiotherapy. The International Commission on Radiation Units and Measurements (ICRU) report 62 recommended a margin added to the clinical target volume (CTV) to produce the planning target volume (PTV). In ICRU report 83, this concept is further extended and refined to yield the internal target volume (ITV), which is defined as CTV plus a margin to account for uncertainty within the patient. Image-guided radiotherapy (IGRT) has been developed as a method to lower the margin required in PTV expansion. In current practice, IGRT methods mostly rely on bony anatomy alignment. Due to its nature, internal organ motion cannot be compensated by IGRT. Therefore, an ITV expansion is still required. The optimal ITV expansion margin depends on the magnitude of internal organ motion; the smallest margin that provides adequate coverage is preferred.
In this study, we aim to quantify organ motion of the sigmoid colon anastomosis site during radiotherapy treatment, including movement between fractions (interfraction) and movement within the same fraction (intrafraction).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sigmoid Cancer, Sigmoid Colon Cancer
Keywords
Sigmoid colon cancer, Internal organ motion, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adjuvant image-guided radiotherapy
Arm Type
Experimental
Arm Description
Adjuvant radiotherapy with image guidance via cone beam computed tomography. Treatment is identical to the current standard of care.
Intervention Type
Radiation
Intervention Name(s)
Adjuvant image-guided radiotherapy
Intervention Description
Image-guided adjuvant radiotherapy to the sigmoid colon surgical tumor bed and pelvic regional lymph nodes: 45-50.4 Gy in 1.8 Gy/fraction
Primary Outcome Measure Information:
Title
Interfraction sigmoid colon organ motion
Description
Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) compared to simulation CT
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Intrafraction sigmoid colon organ motion
Description
Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) between pre-treatment cone beam computed tomography (CBCT) and post-treatment CBCT
Time Frame
90 days
Title
Setup errors
Description
Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with pathologically confirmed sigmoid colon cancer, who have received surgical excision (AR or LAR).
Anastomosis of the colon must be performed with a surgical stapler, with the staple visible on CT imaging.
Exclusion Criteria:
Gross recurrent disease (defined as visible mass on CT imaging) in the pelvis.
Other malignancy within the pelvic cavity.
Previous surgery to the pelvic cavity other than AR/LAR.
Pregnant or lactating females.
Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mu-Hung Tsai, MD
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Sigmoid Colon Organ Motion in Radiotherapy
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