RAPIDO vs LCRT vs Upfront Surgery - a Prospective Cohort Study
RAPIDO
Novel Objective Comparison of Short-term Surgical Outcomes From Total Mesorectal Excision Between Total Neoadjuvant Therapy - Rapido Protocol, Standard Long Course Radiotherapy and Upfront Surgery
1 other identifier
observational
57
0 countries
N/A
Brief Summary
Aim: We evaluated the surgical outcomes of 3 groups of patients with rectal cancers - RAPIDO vs standard long course radiotherapy (LCRT) vs upfront surgery to objectively determine the effects of TNT on TME. Methods: A review of prospectively collected data was performed for patients who have rectal cancer and underwent low anterior resection from January 2016 to May 2022. Data on patient demographics, disease staging, peri-operative details and up to 2-year follow-up outcomes were analysed. The surgical and oncological outcomes were compared. Patients were followed up until 31 May 2022.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2016
Longer than P75 for all trials
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
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedFirst Submitted
Initial submission to the registry
December 27, 2023
CompletedFirst Posted
Study publicly available on registry
January 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedApril 30, 2026
April 1, 2026
6.4 years
December 27, 2023
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
operative time required for primary resection of rectal tumour
operative time in minutes
1 day
Secondary Outcomes (5)
intraoperative blood loss
30 days post surgery
duration to stoma functioning
14 days post surgery
failure to remove urinary catheter
14 days post surgery
presence of post op ileus (defined as >7 days intolerance to diet or no stoma output from time of operation)
14 days post surgery
duration of hospitalisation
30 days after surgery
Study Arms (3)
RAPIDO TNT
neoadjuvant therapy per RAPIDO protocol
LCRT
long course chemoradiotherapy
upfront surgery
directly went for surgery after diagnosis of rectal cancer
Interventions
neoadjuvant therapy per RAPIDO protocol (Patients under RAPIDO group underwent 25Gy/5 sessions of short course radiotherapy followed by 6 cycles of neoadjuvant XELOX similar to that of the RAPIDO trial protocol)
LCRT group underwent conventional 50Gy/25-28 sessions of long course radiotherapy with concurrent oral capecitabine
Eligibility Criteria
as above
You may qualify if:
- diagnosed with rectal cancer
- due to undergo ultra-low anterior resection (ULAR)
You may not qualify if:
- emergency surgery
- unresectable metastatic disease at presentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
December 27, 2023
First Posted
January 18, 2024
Study Start
January 1, 2016
Primary Completion
May 31, 2022
Study Completion
March 30, 2026
Last Updated
April 30, 2026
Record last verified: 2026-04