NCT03259828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

December 6, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

August 21, 2017

Last Update Submit

February 4, 2021

Conditions

Sigmoid CancerSigmoid Colon Cancer

Keywords

Sigmoid colon cancerInternal organ motionRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Interfraction sigmoid colon organ motion

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

    90 days

Secondary Outcomes (2)

  • Intrafraction sigmoid colon organ motion

    90 days

  • Setup errors

    90 days

Study Arms (1)

Adjuvant image-guided radiotherapy

EXPERIMENTAL

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

Radiation: Adjuvant image-guided radiotherapy

Interventions

Adjuvant image-guided radiotherapyRADIATION

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

Adjuvant image-guided radiotherapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Sigmoid Neoplasms

Condition Hierarchy (Ancestors)

Colonic NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesSigmoid Diseases

Study Officials

  • Mu-Hung Tsai, MD

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 24, 2017

Study Start

December 6, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)