- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06212128
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A review of prospectively collected data was performed for all patients who were diagnosed with rectal cancer and who underwent ultra-low anterior resection (ULAR) from January 2016 to May 2022 in a single institution in Singapore. Exclusion criteria of this study included patients who underwent emergency surgery and patients with unresectable metastatic disease at presentation. All patients were discussed at multi-disciplinary tumour board for recommendation and decision of the respective treatment protocols. Patients were analysed in 3 main categories: neoadjuvant therapy per RAPIDO protocol, LCRT and upfront surgery. 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 while patients in LCRT group underwent conventional 50Gy/25-28 sessions of long course radiotherapy with concurrent oral capecitabine. All cases were performed by 7 consultant-grade colorectal surgeons in the department.
Patient demographics and peri-operative details were collected. Histopathological stage of disease was in accordance with the American Joint Committee on Cancer (AJCC) staging manual after surgical resection with review of the resected specimen by consultant-grade pathologists who were blinded to the type of pre-operative treatment the patients received.
Primary outcome for the study was the operative time required for primary resection of rectal tumour. If combined surgery was performed for oligometastatic disease, we removed the operating time for non-rectal component as this was separately defined in the operation notes.
Secondary outcomes included the intraoperative blood loss, duration to stoma function, failure to remove urinary catheter, presence of post-operative ileus, duration of hospitalisation after surgery. Presence of stoma function was defined as enteric content of significant amount (>200ml or presence of formed faecal material). Failure of removal of urinary catheter is defined as acute urinary retention requiring re-insertion of catheter post-operatively. Post-operative ileus is defined as ileus which persist beyond 7 days from operation.
Follow-up outcomes and data for patients were collected until 31 May 2022. Local-regional recurrence was defined as the first clinical, radiologic and/or pathologic evident tumour of the same histological type at the region of the anastomosis and pelvis. Distant recurrent was defined similarly at sites outside primary malignancy such as liver, lung, bone, brain, para-aortic region. Presence of recurrence in patients was recorded, disease-free interval was calculated in months from date of surgery to date of recurrence.
Statistical analysis All data was analysed with SPSS version 28 (SPSS Inc, Chicago, III). Patients with missing data were accounted for and excluded during the statistical analysis of this data. Categorical variables were presented as percentages while median and interquartile ranges were presented for continuous variables. Differences between categorical variables were analysed using either Chi-square or Student t-test. Differences between continuous variables were treated as non-parametric and analysed using either Kruskal Willis or Mann-Whitney U. Two-sided tests were used, with p value <0.05 treated as significant. Kaplan Meier curves were plotted for survival data including disease free survival and overall survival.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- diagnosed with rectal cancer
- due to undergo ultra-low anterior resection (ULAR)
Exclusion Criteria:
- emergency surgery
- unresectable metastatic disease at presentation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RAPIDO TNT
neoadjuvant therapy per RAPIDO protocol
|
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
long course chemoradiotherapy
|
LCRT group underwent conventional 50Gy/25-28 sessions of long course radiotherapy with concurrent oral capecitabine
|
upfront surgery
directly went for surgery after diagnosis of rectal cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
operative time required for primary resection of rectal tumour
Time Frame: 1 day
|
operative time in minutes
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intraoperative blood loss
Time Frame: 30 days post surgery
|
in ml
|
30 days post surgery
|
duration to stoma functioning
Time Frame: 14 days post surgery
|
in days
|
14 days post surgery
|
failure to remove urinary catheter
Time Frame: 14 days post surgery
|
yes/no, and in days to successful removal
|
14 days post surgery
|
presence of post op ileus (defined as >7 days intolerance to diet or no stoma output from time of operation)
Time Frame: 14 days post surgery
|
yes/no
|
14 days post surgery
|
duration of hospitalisation
Time Frame: 30 days after surgery
|
in days from time of surgery
|
30 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRB: 2020/2525
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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