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Multimodality treatment including surgery and radiotherapy is the current standard of care in locally advanced rectal cancer. Most clinical trials comparing short course radiotherapy (SCRT) with long course chemoradiotherapy(LCRT) did not find significant differences in oncological outcomes and short-term outcomes even though some debates. Recently, Stockholm III trial comparing SCRT plus delayed surgery with SCRT plus immediate surgery and LCRT demonstrated no differences with respect to short-term outcomes such as complications, mortality, and acute toxicity. However, overall quality of life (QoL) after curative treatment for rectal cancer is still major concern in both SCRT and LCRT. Furthermore, daily hospital visits for 5 weeks may be the cause of the increase of total medical cost due to indirect medical expense in patients with LCRT, especially in rural area. SCRT plus chemotherapy followed by delayed surgery may have the possibility of reducing total hospital costs as well as increasing QoL by proving non-inferiority in terms of perioperative outcomes. The present prospective single-arm phase 2 trial was designed to validate the efficacy, quality of life and cost effectiveness of preoperative short-course radiotherapy plus XELOX chemotherapy followed by delayed surgery for high-risk rectal cancer patient based on magnetic resonance imaging.
Age
19 - 80 years
Sex
ALL
Healthy Volunteers
No
The Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine
Seoul, South Korea
Start Date
March 1, 2019
Primary Completion Date
August 1, 2023
Completion Date
August 1, 2023
Last Updated
February 15, 2019
31
ESTIMATED participants
preoperative short-course radiotherapy
RADIATION
Lead Sponsor
Yonsei University
NCT05412082
NCT06204094
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View ClinicalTrials.gov Terms and ConditionsNCT05054959