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Clinical trial

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

ID
Name
CIRB: 2020/2525
Description
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 arms
Trial start
2016-01-01
Estimated PCD
2022-05-31
Trial end
2024-06-30
Status
Active (not recruiting)
Treatment
RAPIDO TNT
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)
Arms:
RAPIDO TNT
LCRT
LCRT group underwent conventional 50Gy/25-28 sessions of long course radiotherapy with concurrent oral capecitabine
Arms:
LCRT
Size
57
Primary endpoint
operative time required for primary resection of rectal tumour
1 day
Eligibility criteria
Inclusion Criteria: * diagnosed with rectal cancer * due to undergo ultra-low anterior resection (ULAR) Exclusion Criteria: * emergency surgery * unresectable metastatic disease at presentation
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '36 Months', 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 57, 'type': 'ACTUAL'}}
Updated at
2024-01-18

1 organization

2 products

1 indication

Organization
Sengkang General Hospital
Product
RAPIDO TNT
Indication
Rectal Cancer
Product
LCRT