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Factors Predicting Recurrence in Rectal Cancer After Surgery

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ClinicalTrials.gov Identifier: NCT03899870
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
ammar houssem, Université de Sousse

Tracking Information
First Submitted Date March 28, 2019
First Posted Date April 2, 2019
Last Update Posted Date April 2, 2019
Actual Study Start Date January 1, 2000
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 30, 2019)
Recurrence [ Time Frame: through study completion at average of 5 years ]
the development of any new malignant lesion within the field of surgery (locoregional recurrence) or outside it (distant metastasis) after initial resection was judged to be curative (R0) based on the preoperative imaging and histopathological examination of the resected specimen.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Factors Predicting Recurrence in Rectal Cancer After Surgery
Official Title Factors Predicting Recurrence After Curative Resection for Rectal Cancer: a 16-year Study
Brief Summary

Colorectal cancer is one of the most frequently diagnosed cancers and a major cause of cancer deaths worldwide. Recurrence after curative surgery is one of the major factors affecting the long-term survival and its frequency is estimated to be 22.5% at 5 years. of which 12% have local recurrence. The overall survival in case of recurrence of 11% at 5 years.

Several patient-, tumor-related and treatment-related prognostic factors have been found to be associated with the risk of recurrence of rectal adenocarcinoma. Some of these factors such as TNM stage, lymphatic and perineural invasion and vascular emboli have been found to affect recurrence free survival in most studies. While the impact of other factors such as distal resection margin, tumor size, extra capsular spread and neoadjuvant chemoradiotherapy on recurrence remains controversial. Moreover, most of the previous studies on prognostic factors have been from American and European countries with very little data from African countries. Recognition of these factors helps in identification of high-risk patients who require close and more rigorous postoperative surveillance. Hence this study was conducted to determine the factors affecting recurrence after curative resection of rectal cancer in African population.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with rectal adenocarcinoma who underwent curative resection
Condition
  • Rectal Cancer
  • Rectal Adenocarcinoma
Intervention
  • Procedure: Rectal resection
    Patients underwent anterior or low anterior resection. Patients with tumors in the lower third of the rectum where anal sphincters could not be preserved underwent abdominoperineal resection. In majority of the cases, inferior mesenteric artery (IMA) was ligated caudal to the origin of the left colic artery. For the tumors of the upper rectum, partial excision of the mesorectum was performed up to the minimum of 5 cm from the inferior aspect of the tumor. For the tumors of the middle and low rectum a total mesorectum excision was done with the minimum distal mucosal margin of 1 to 2 cm. Ileostomy was performed in cases where colon was poorly prepared, anastomotic leak test was positive or colonel anastomosis was made. In most of the cases, open surgery was performed. Laparoscopic surgery was performed in selected cases. Wide local excision was performed in selected cases with T1 tumors without locoregional lymphadenopathy.
  • Drug: Neoadjuvant therapy
    Patients with locally advanced disease (T3, T4) or lymph nodal positive disease were offered neoadjuvant therapy. In the neoadjuvant therapy, we used 45 Gy in 25 fractions with concurrent 5-fluorouracil [5-FU] and patients were operated 8 to 10 weeks after neoadjuvant therapy. In some cases, especially the elderly patients with multiple co-morbidities, we used short-course pelvic radiation therapy which included 25 Gy in 5 fractions over 1 week.
  • Drug: Adjuvant therapy
    Patients with locally advanced disease (T3, T4) or lymph nodal positive disease were offered adjuvant therapy. In most of the cases, FOLFOX (leucovorin, 5-FU, oxaliplatin) regimen was used and for elderly patients who could not tolerated this regimen, we used oral capecitabine.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 30, 2019)
188
Original Actual Enrollment Same as current
Actual Study Completion Date January 15, 2019
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

- all the patients who underwent curative resection for rectal adenocarcinoma between January 2000 and December 2015 at the Department of Digestive and Visceral Surgery of Sahloul Hospital, Sousse, Tunisia

Exclusion Criteria:

  • patients who underwent palliative surgery
  • patients with microscopically or macroscopically positive resection margin
  • patients with tumors other than adenocarcinoma
  • patients who died in the postoperative period due to complications.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03899870
Other Study ID Numbers 654285
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party ammar houssem, Université de Sousse
Study Sponsor ammar houssem
Collaborators Not Provided
Investigators Not Provided
PRS Account Université de Sousse
Verification Date March 2019