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

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.

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Progression Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Batna anticancer center, Algiers, Algeria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectal Resection

Procedure

total mesorectal excision

Primary outcomes

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.
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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Moroccan Society of Surgery

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2013
Study completion: 2016
First posted: Jul 26, 2018
Registry last updated: Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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