Sigmoid Colon Organ Motion in Radiotherapy

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03259828
Collaborator
(none)
4
1
1
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Adjuvant image-guided radiotherapy
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Interfraction and Intrafraction Organ Motion of the Sigmoid Colon in Patients With Colorectal Cancer Undergoing Adjuvant Radiotherapy
Actual Study Start Date :
Dec 6, 2017
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adjuvant image-guided radiotherapy

Adjuvant radiotherapy with image guidance via cone beam computed tomography. Treatment is identical to the current standard of care.

Radiation: Adjuvant image-guided radiotherapy
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

Outcome Measures

Primary Outcome Measures

  1. Interfraction sigmoid colon organ motion [90 days]

    Offset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) compared to simulation CT

Secondary Outcome Measures

  1. Intrafraction sigmoid colon organ motion [90 days]

    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

  2. Setup errors [90 days]

    Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng Kung University Hospital Tainan Taiwan 704

Sponsors and Collaborators

  • National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Mu-Hung Tsai, MD, National Cheng-Kung University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tsai, Mu-Hung, Attending Physician, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT03259828
Other Study ID Numbers:
  • A-BR-106-037
First Posted:
Aug 24, 2017
Last Update Posted:
Feb 8, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tsai, Mu-Hung, Attending Physician, National Cheng-Kung University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2021