An interventional study of Adjuvant image-guided radiotherapy in Sigmoid Cancer and Sigmoid Colon Cancer, sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment
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.
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).
20 studies on the registry are indexed under Sigmoid Neoplasms; 5 are open to participants now.
This study's enrollment of 4 is below the median of 55 across 14 interventional studies indexed under Sigmoid Neoplasms.
Browse Sigmoid Neoplasms studies →National Cheng-Kung University Hospital is the lead sponsor of 277 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
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The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: 90 days
Intrafraction sigmoid colon organ motion
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
Time frame: 90 days
Setup errors
Offset of couch (set-up error) when matching the pre-treatment CBCT with simulation CT
Time frame: 90 days
Plan to share: No
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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