- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601689
Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma
July 24, 2018 updated by: Moroccan Society of Surgery
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
84
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alger, Algeria
- Batna anticancer center
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Fès, Morocco
- Sidi Mohammed Ben Abdellah University Medical School, Surgery Department,
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Oujda, Morocco
- Mohammed Ist University Medical School, Surgical Oncology, Hospital el Farabi
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Salé, Morocco
- Private surgical oncology center
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Please Enter The State Or Province
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Rabat, Please Enter The State Or Province, Morocco, 10001
- Mohammed V University Medical School, Surgery Department, Military Hospital
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Rabat, Please Enter The State Or Province, Morocco, 10001
- Mohammed V University Medical School, Surgical Department "A", Ibn Sina Hospital
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Rabat, Please Enter The State Or Province, Morocco, 10001
- Mohammed V University Medical School, Surgical Department "C", Ibn Sina Hospital,
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Rabat, Please Enter The State Or Province, Morocco, 10001
- National Institut of Oncology, Surgical oncology department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Local recurrence rate
Time Frame: From date of surgery until the date of first documented local progression assessed up to 100 months
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A postoperative local recurrence was defined by biopsy-proven or radiographic evidence of local recurrent disease.
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From date of surgery until the date of first documented local progression assessed up to 100 months
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Distant recurrence rate
Time Frame: From date of surgery until the date of first documented distant progression assessed up to 100 months
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A postoperative distant recurrence was defined by biopsy-proven or radiographic evidence of distant recurrent disease.
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From date of surgery until the date of first documented distant progression assessed up to 100 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2005
Primary Completion (Actual)
December 31, 2013
Study Completion (Actual)
March 31, 2016
Study Registration Dates
First Submitted
July 14, 2018
First Submitted That Met QC Criteria
July 24, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
July 26, 2018
Last Update Submitted That Met QC Criteria
July 24, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Adenocarcinoma
- Rectal Neoplasms
Other Study ID Numbers
- CompleteResponse
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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