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

Rectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601689
• Other study ID #: CompleteResponse
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: March 31, 2016

Study information

• Verified date: July 2018
• Source: Moroccan Society of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 31, 2016
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Neoplasms

Intervention

Procedure:
• rectal resection
total mesorectal excision

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Moroccan Society of Surgery

Countries where clinical trial is conducted

Algeria,  Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence rate	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
Primary	Distant recurrence rate	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	Predictive factors of disease free survival	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