Prognostic Factors Affecting Recurrence and Disease-Free Survival After Surgical Resection for Cancer Rectum

Rectal Cancer Clinical Trial

Official title:

Predictors of Disease Free Survival After Curative Cancer Rectum Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096493
• Other study ID #: SVU-MED-SUR011-4-23-4-621
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: South Valley University
• Contact: Abdallah M Taha, MD
• Phone: +201011716497
• Email: abdallahsurgery[@]med.svu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tumor recurrence after curative surgical resection for rectal cancer is a serious complication that greatly affects the overall morbidity and the outcome. This study aims to identify the different prognostic factors affecting recurrence and disease-free survival after surgery.

Description:

A retrospective analysis of patients operated for cancer rectum with curative intent from.

Exclusion criteria will include patients with familial adenomatous polyposis, multiple synchronous or metachronous rectal cancers, and death within 3 months. Incomplete patients' files and patients that lost follow-up will be excluded.

Demographic, histopathological, follow up and outcome data will be collected from completed patients' files. Demographics include age, gender, family history, and chief complaint at the presentation. Histopathological data include tumor grade, vascular-perineural invasion, the total number of lymph nodes removed, and positive lymph nodes.

Lymph node ratio will be defined as the ratio of positive lymph nodes to the total number of retrieved lymph nodes in a histopathology specimen. Disease-free survival will be calculated for each patient based on the time of surgery to the time of recurrence detection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients who had curative surgery for cancer rectum.

Exclusion Criteria:

• Patients with familial adenomatous polyposis (FAP), multiple synchronous or metachronous rectal cancers, and death within 3 months

• Patients that lost follow-up will be excluded.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Recurrence

Intervention

Procedure:
• curative surgery for cancer rectum
Curative surgery for cancer rectum.

Locations

Country	Name	City	State
Egypt	Qena Faculty of Medicine, South Valley University Hospitals	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Feeney G, Sehgal R, Sheehan M, Hogan A, Regan M, Joyce M, Kerin M. Neoadjuvant radiotherapy for rectal cancer management. World J Gastroenterol. 2019 Sep 7;25(33):4850-4869. doi: 10.3748/wjg.v25.i33.4850. — View Citation

Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, Hotta K, Ishida H, Ishiguro M, Ishihara S, Kanemitsu Y, Kinugasa Y, Murofushi K, Nakajima TE, Oka S, Tanaka T, Taniguchi H, Tsuji A, Uehara K, Ueno H, Yamanaka T, Yamazaki K, Yoshida M, Yoshino T, Itabashi M, Sakamaki K, Sano K, Shimada Y, Tanaka S, Uetake H, Yamaguchi S, Yamaguchi N, Kobayashi H, Matsuda K, Kotake K, Sugihara K; Japanese Society for Cancer of the Colon and Rectum. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020 Jan;25(1):1-42. doi: 10.1007/s10147-019-01485-z. Epub 2019 Jun 15. — View Citation

He WZ, Xie QK, Hu WM, Kong PF, Yang L, Yang YZ, Jiang C, Yin CX, Qiu HJ, Zhang HZ, Zhang B, Xia LP. An increased number of negative lymph nodes is associated with a higher immune response and longer survival in colon cancer patients. Cancer Manag Res. 2018 Jun 18;10:1597-1604. doi: 10.2147/CMAR.S160100. eCollection 2018. — View Citation

Heald RJ, Husband EM, Ryall RD. The mesorectum in rectal cancer surgery--the clue to pelvic recurrence? Br J Surg. 1982 Oct;69(10):613-6. doi: 10.1002/bjs.1800691019. — View Citation

Li Destri G, Di Carlo I, Scilletta R, Scilletta B, Puleo S. Colorectal cancer and lymph nodes: the obsession with the number 12. World J Gastroenterol. 2014 Feb 28;20(8):1951-60. doi: 10.3748/wjg.v20.i8.1951. — View Citation

Tschmelitsch J, Kronberger P, Glaser K, Klingler A, Bodner E. Survival after surgical treatment of recurrent carcinoma of the rectum. J Am Coll Surg. 1994 Jul;179(1):54-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor recurrence	Presence of Tumor recurrence after curative surgery for cancer rectum.	Through study completion, an average of 3 year
Primary	Disease free survival.	From date of surgery until the date of recurrence detection.	up to 5 years