Sigmoid Colon Organ Motion in Radiotherapy

Not Applicable

Completed

• Conditions: Sigmoid Cancer; Sigmoid Colon Cancer
• Interventions: Radiation: Adjuvant image-guided radiotherapy

• Registration Number: NCT03259828
• Lead Sponsor: National Cheng-Kung University Hospital

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).

Study Timeline

• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-24
• Study Start: 2017-12-06
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Setup errors	90 days	Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan