NCT06212128

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

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

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

6.4 years

First QC Date

December 27, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

Rectal CancerSurgical outcomesNeoadjuvant treatment

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

Combination Product: RAPIDO TNT

LCRT

long course chemoradiotherapy

Combination Product: LCRT

upfront surgery

directly went for surgery after diagnosis of rectal cancer

Interventions

RAPIDO TNTCOMBINATION_PRODUCT

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)

RAPIDO TNT
LCRTCOMBINATION_PRODUCT

LCRT group underwent conventional 50Gy/25-28 sessions of long course radiotherapy with concurrent oral capecitabine

LCRT

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

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