NCT04717947

Brief Summary

The investigators evaluate the response of rectal cancer to neoadjuvant therapy and classify the response according to specific periods of time after the end of neoadjuvant treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
911

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2021

Completed
Last Updated

February 4, 2021

Status Verified

October 1, 2020

Enrollment Period

Same day

First QC Date

October 2, 2020

Last Update Submit

February 1, 2021

Conditions

Rectal CancerNeoadjuvant Therapy

Outcome Measures

Primary Outcomes (4)

  • Pathological response

    Grade as complete

    2000-2019

  • Circumferential margin (CRM)

    Described as free (CRM \>1 mm)

    2000-2019

  • Distal resection margin (DRM)

    Described as free (DRM \>1 mm)

    2000-2019

  • Quality of the specimen

    Described as complete or incomplete

    2000-2019

Study Arms (3)

Short interval group

≤ 8weeks between the end of neoadjuvant therapy and surgery

Procedure: Interval between NAT and surgery

Intermediate interval group

\> 8 and ≤ 12 weeks between the end of neoadjuvant therapy and surgery

Procedure: Interval between NAT and surgery

Long interval group

\> 12 weeks between the end of neoadjuvant therapy and surgery

Interventions

Interval between NAT and surgeryPROCEDURE

Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.

Intermediate interval groupShort interval group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This was a national multicentre retrospective cohort study. Participating centres are tertiary referral hospitals from different Spanish regions, which agreed to enter information in a standardized database, of all patients in their institute who had biopsy-confirmed rectal adenocarcinoma and had received neoadjuvant therapy. All patients with low, mid and high rectal cancer (0-15 cm from the anal verge), at a clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) will be included.

You may qualify if:

  • Adult patients suitable for elective surgical resection of biopsy-confirmed rectal adenocarcinoma (0-15 cm from the anal verge) determined by rectal cancer protocol magnetic resonance imaging.
  • Patients treated with long-course neoadjuvant chemoradiotherapy (nCRT).
  • Patients treated with short-course radiotherapy with delayed surgery.
  • Clinical stage IIA, IIB, IIIA, IIIB, IIIC (cT3/cT4, or cN1/cN2 with any cT, M0) determined by rectal cancer protocol magnetic resonance imaging

You may not qualify if:

  • Intolerance or contraindication to planned NAT.
  • Patients who have not finished NAT for any reason.
  • Patients with unknown cT or cM.
  • Tumors previously treated with local excision or with distant metastatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

  • Antonio Lacy, PhD

    Hospital Clinic of Barcelona

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2020

First Posted

January 22, 2021

Study Start

February 25, 2020

Primary Completion

February 25, 2020

Study Completion

June 25, 2021

Last Updated

February 4, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)