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

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ClinicalTrials.gov Identifier: NCT03601689
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rectal Neoplasms Procedure: rectal resection

Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma
Actual Study Start Date : January 1, 2005
Actual Primary Completion Date : December 31, 2013
Actual Study Completion Date : March 31, 2016

Intervention Details:
  • Procedure: rectal resection
    total mesorectal excision


Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601689


Locations
Algeria
Batna anticancer center
Alger, Algeria
Morocco
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
Rabat, Please Enter The State Or Province, Morocco, 10001
Sidi Mohammed Ben Abdellah University Medical School, Surgery Department,
Fès, Morocco
Mohammed Ist University Medical School, Surgical Oncology, Hospital el Farabi
Oujda, Morocco
Private surgical oncology center
Salé, Morocco
Sponsors and Collaborators
Moroccan Society of Surgery

Responsible Party: Moroccan Society of Surgery
ClinicalTrials.gov Identifier: NCT03601689     History of Changes
Other Study ID Numbers: CompleteResponse
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moroccan Society of Surgery:
Low rectal cancer
Neoadjuvant treatment
Complete pathological response
ypT0N0
disease free survival
Predictive factors

Additional relevant MeSH terms:
Adenocarcinoma
Rectal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases