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

Completed

• Conditions: Rectal Neoplasms

• Registration Number: NCT03601689
• Lead Sponsor: Moroccan Society of Surgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-01
• Primary Completion: 2013-12-31
• Study Completion: 2016-03-31
• Status Verified: 2018-07
• Study First Submitted: 2018-07-14
• Study First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

• all patients with metastatic tumors or missing data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Batna anticancer center; 🇩🇿 Alger, Algeria

Mohammed V University Medical School, Surgical Department "A", Ibn Sina Hospital; 🇲🇦 Rabat, Please Enter The State Or Province, Morocco

Mohammed V University Medical School, Surgical Department "C", Ibn Sina Hospital,; 🇲🇦 Rabat, Please Enter The State Or Province, Morocco

Mohammed Ist University Medical School, Surgical Oncology, Hospital el Farabi; 🇲🇦 Oujda, Morocco

Private surgical oncology center; 🇲🇦 Salé, Morocco

National Institut of Oncology, Surgical oncology department; 🇲🇦 Rabat, Please Enter The State Or Province, Morocco

Mohammed V University Medical School, Surgery Department, Military Hospital; 🇲🇦 Rabat, Please Enter The State Or Province, Morocco

Sidi Mohammed Ben Abdellah University Medical School, Surgery Department,; 🇲🇦 Fès, Morocco