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Completed

NCT Number: NCT03259828

Sigmoid Colon Organ Motion in Radiotherapy

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adjuvant image-guided radiotherapy

Radiation

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 outcomes

  1. Interfraction sigmoid colon organ motion

    Time frame: 90 days

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

Secondary outcomes

  1. Intrafraction sigmoid colon organ motion

    Time frame: 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

    Time frame: 90 days

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

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2017
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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