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Sigmoid Colon Organ Motion in Radiotherapy

Interfraction and Intrafraction Organ Motion of the Sigmoid Colon in Patients With Colorectal Cancer Undergoing Adjuvant Radiotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03259828
Enrollment
4
Registered
2017-08-24
Start date
2017-12-06
Completion date
2020-12-31
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sigmoid Cancer, Sigmoid Colon Cancer

Keywords

Sigmoid colon cancer, Internal organ motion, Radiotherapy

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).

Interventions

RADIATIONAdjuvant 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

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Interfraction sigmoid colon organ motion90 daysOffset of the sigmoid colon staple site in three axes (anterior-posterior, lateral, and cranial-caudal) compared to simulation CT

Secondary

MeasureTime frameDescription
Intrafraction sigmoid colon organ motion90 daysOffset 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 errors90 daysOffset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026