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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03601689

Enrollment

Registered

2018-07-26

Start date

2005-01-01

Completion date

2016-03-31

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

Keywords

Low rectal cancer, Neoadjuvant treatment, Complete pathological response, ypT0N0, disease free survival, Predictive factors

Brief summary

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.

Interventions

PROCEDURErectal resection

total mesorectal excision

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Local recurrence rate	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	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

Measure	Time frame	Description
Predictive factors of disease free survival	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

Countries

Algeria, Morocco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026