NCT03676517

Evaluation of Efficacy, Quality of Life and Cost Effectiveness of Short-course Radiotherapy Followed by Capecitabine Plus Oxaliplatin chemotheRapy and TME for High-risk Rectal Cancer (ESCORT Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
RADIATION	preoperative short-course radiotherapy	1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME)

Timeline

• Start date: 2019-03-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2018-09-18
• Last updated: 2019-02-15

Locations

1 site across 1 country: South Korea