NCT03607370

Brief Summary

The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 8 weeks. Hypothesis: Greater down-staging and tumor regression is observed when surgery is delayed to 12 weeks after completion of chemoradiotherapy compared to 8 weeks.

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
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

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

July 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

6.5 years

First QC Date

June 20, 2018

Last Update Submit

November 7, 2023

Conditions

Rectal Cancer

Keywords

Rectal cancerChemoradiotherapySurgery

Outcome Measures

Primary Outcomes (1)

  • Complete pathologic response assessed by pathologist Dworak scale

    Dworak scale assesses the response: 0. No regression; 1. Predominantly tumor with significant fibrosis and/or vasculopathy; 2. Predominantly fibrosis with scattered tumor cells (slightly recognizable histologically); 3. Only scattered tumor cells in the space of fibrosis with/without acellular mucin; 4. No vital tumor cells detectable

    6 months

Secondary Outcomes (14)

  • Clinical response assessed using MRi

    8 weeks (2 months)

  • Pathological response assessed by pathologist using Dworak scale

    6 months

  • Incidence of Treatment-Emergent Adverse Events as assessed by Clavien-Dindo scale

    30 days

  • Incidence of Mortality assessed by Clavien-Dindo scale

    30 days

  • Total mesorectal excision (TME) quality assessed by TME completeness scale (by P.Quircke)

    8-12 weeks

  • +9 more secondary outcomes

Study Arms (2)

Group 1

NO INTERVENTION

The cancer surgery is practice 8 weeks after neoadjuvant chemoradiotherapy

Group 2

EXPERIMENTAL

The cancer surgery will be performed in 12 weeks after neoadjuvant chemoradiotherapy

Procedure: Surgery after 12 weeks of delay after chemoradiotherapy.

Interventions

Surgery after 12 weeks of delay after chemoradiotherapy.PROCEDURE

Surgery consists oncologic resection of the rectal cancer with total excision of the mesorectum after 12 weeks of delay after the end of chemoradiotherapy.

Group 2

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • Eastern Cooperative Oncology Group (ECOG) 0-1,
  • American Society of Anesthesiologists' (ASA) score I-III
  • Histological confirmation of adenocarcinoma of rectum
  • T3 or T4 N0, T any N positive cancer on MRI, without metastasis on CT scan
  • Undergoing preoperative radiotherapy/ chemotherapy
  • Curative total mesorectal excision intended
  • Written informed consent
  • Patients undergoing preoperative radiotherapy should not be excluded

You may not qualify if:

  • Patients with distant metastasis
  • T1 or T2, N0 cancer on MRI
  • Rectal cancer 12 cm above the dentate line
  • Contraindications to MRI
  • Patients previously treated of pelvic organ cancer
  • Medical or psychiatric conditions that compromise the patients ability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Vilnius, 08406, Lithuania

Location

Related Publications (2)

  • Didrikaite G, Klimovskij M, Civilka I, Buckus B, Aukstikalnis T, Sileika E, Dulskas A. Quality of life following ileostomy takedown: single-centre, retrospective clinical trial-does closure time matter? Tech Coloproctol. 2025 Jul 30;29(1):154. doi: 10.1007/s10151-025-03196-2.

    PMID: 40736758DERIVED

  • Gricius Z, Kuliavas J, Stratilatovas E, Buckus B, Dulskas A. Early urinary catheter removal in patients undergoing rectal cancer surgery: a randomized controlled trial on silodosin versus no pharmacological treatment on urinary function in the early postoperative period. Ann Coloproctol. 2025 Jun;41(3):239-245. doi: 10.3393/ac.2024.00703.0100. Epub 2025 Jun 20.

    PMID: 40537941DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Audrius Dulskas, MD, PhD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. profesor

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 31, 2018

Study Start

July 1, 2017

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations

LI(1)