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Sigmoid Colon Organ Motion in Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03259828
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : September 14, 2020
Information provided by (Responsible Party):
Tsai, Mu-Hung, 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.

Condition or disease Intervention/treatment Phase
Sigmoid Cancer Sigmoid Colon Cancer Radiation: Adjuvant image-guided radiotherapy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 : December 6, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03259828

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Contact: Mu-Hung Tsai, MD +886-6-2353535 ext 2461

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National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Mu-Hung Tsai, MD    +8862353535 ext 2461   
Principal Investigator: Mu-Hung Tsai, MD         
Sub-Investigator: Helen H.W. Chen, MD, PhD         
Sub-Investigator: Yuan-Hua Wu, MD         
Sub-Investigator: Jung-Jen Cheng, MD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
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Principal Investigator: Mu-Hung Tsai, MD National Cheng-Kung University Hospital
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Responsible Party: Tsai, Mu-Hung, Attending Physician, National Cheng-Kung University Hospital Identifier: NCT03259828    
Other Study ID Numbers: A-BR-106-037
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tsai, Mu-Hung, National Cheng-Kung University Hospital:
Sigmoid colon cancer
Internal organ motion
Additional relevant MeSH terms:
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Colonic Neoplasms
Sigmoid Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Sigmoid Diseases