Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma

July 24, 2018 updated by: Moroccan Society of Surgery

Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This retrospective multicentric study aimed to predict the prognosis of patients with complete pathological response after neoadjuvant treatment.

Study Overview

Status

Completed

Conditions

Rectal Neoplasms

Intervention / Treatment

Procedure: rectal resection

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Algeria
- - Alger, Algeria
    - Batna anticancer center
Morocco
- - Fès, Morocco
    - Sidi Mohammed Ben Abdellah University Medical School, Surgery Department,
  - Oujda, Morocco
    - Mohammed Ist University Medical School, Surgical Oncology, Hospital el Farabi
  - Salé, Morocco
    - Private surgical oncology center
- Please Enter The State Or Province
  - Rabat, Please Enter The State Or Province, Morocco, 10001
    - Mohammed V University Medical School, Surgery Department, Military Hospital
  - Rabat, Please Enter The State Or Province, Morocco, 10001
    - Mohammed V University Medical School, Surgical Department "A", Ibn Sina Hospital
  - Rabat, Please Enter The State Or Province, Morocco, 10001
    - Mohammed V University Medical School, Surgical Department "C", Ibn Sina Hospital,
  - Rabat, Please Enter The State Or Province, Morocco, 10001
    - National Institut of Oncology, Surgical oncology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients who underwent neoadjuvant treatment followed by total mesorectal excision for rectal adenocarcinoma in 8 centers

Description

Inclusion Criteria

patients with a histologically proven low rectal adenocarcinoma,
no previous or synchronous colorectal disease,
UICC stage I-III patients who underwent neoadjuvant chemoradiotherapy or chemotherapy,
followed by total mesorectal excision (TME), and
a complete pathological response defined as ypT0N0

Exclusion Criteria:

- all patients with metastatic tumors or missing data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence rate Time Frame: From date of surgery until the date of first documented local progression assessed up to 100 months	A postoperative local recurrence was defined by biopsy-proven or radiographic evidence of local recurrent disease.	From date of surgery until the date of first documented local progression assessed up to 100 months
Distant recurrence rate Time Frame: From date of surgery until the date of first documented distant progression assessed up to 100 months	A postoperative distant recurrence was defined by biopsy-proven or radiographic evidence of distant recurrent disease.	From date of surgery until the date of first documented distant progression assessed up to 100 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive factors of disease free survival Time Frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	Disease free survival was defined as the period between the day of surgery and the date of recurrence or the last date of follow-up	From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moroccan Society of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Souadka A, Majbar MA, Benkabbou A, Serji B, Souiki T, Bouchentouf SM, Abid M, El Khannousi B, El Harroudi T, El Malki HO, Raiss M, Ifrine L, Mazaz K, Zentar A, Mohsine R, Souadka A, Belkouchi A, Ahallat M, Hrora A; Moroccan Society of Surgery. Predictive factors of disease-free survival after complete pathological response to neoadjuvant radiotherapy for rectal adenocarcinoma: retrospective case series. BMC Cancer. 2019 Oct 28;19(1):1008. doi: 10.1186/s12885-019-6239-3.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

December 31, 2013

Study Completion (Actual)

March 31, 2016

Study Registration Dates

First Submitted

July 14, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)