Effect of Age, Body Mass Index and Tumor Sidedness in Metastatic Colorectal Cancer

NCT04543019 | Unknown

• 1 other identifier: systemic therapy in mCRC
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer in relation to age, BMI and tumor sidedness, describing their predictive influence on systemic therapy outcome.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) and overall survival (OS)

  Progression free survival (PFS) and overall survival (OS) in metastatic colorectal cancer patients in correlation to age, BMI and tumor sidedness.

  between January 2015 and December 2019

Secondary Outcomes (1)

• response to systemic therapy

  between January 2015 and December 2019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total coverage sample will be used. Fifty patients having the inclusion criteria who presented to Clinical oncology department, Assiut university hospital between January 2015 to December 2019 will be included.

You may qualify if:

• Age \>18 years.
• Pathologically proven colon or rectal adenocarcinoma.
• Stage IV colorectal cancer.

You may not qualify if:

• Age \<18 years.
• Not pathologically proven colon or rectal adenocarcinoma.
• Stage I, II and III colorectal cancer.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (12)

• Yoshino T, Arnold D, Taniguchi H, Pentheroudakis G, Yamazaki K, Xu RH, Kim TW, Ismail F, Tan IB, Yeh KH, Grothey A, Zhang S, Ahn JB, Mastura MY, Chong D, Chen LT, Kopetz S, Eguchi-Nakajima T, Ebi H, Ohtsu A, Cervantes A, Muro K, Tabernero J, Minami H, Ciardiello F, Douillard JY. Pan-Asian adapted ESMO consensus guidelines for the management of patients with metastatic colorectal cancer: a JSMO-ESMO initiative endorsed by CSCO, KACO, MOS, SSO and TOS. Ann Oncol. 2018 Jan 1;29(1):44-70. doi: 10.1093/annonc/mdx738.

  PMID: 29155929 BACKGROUND

• El-Deiry WS, Vijayvergia N, Xiu J, Scicchitano A, Lim B, Yee NS, Harvey HA, Gatalica Z, Reddy S. Molecular profiling of 6,892 colorectal cancer samples suggests different possible treatment options specific to metastatic sites. Cancer Biol Ther. 2015;16(12):1726-37. doi: 10.1080/15384047.2015.1113356.

  PMID: 26553611 BACKGROUND

• Labianca R, Nordlinger B, Beretta GD, Mosconi S, Mandala M, Cervantes A, Arnold D; ESMO Guidelines Working Group. Early colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi64-72. doi: 10.1093/annonc/mdt354. No abstract available.

  PMID: 24078664 BACKGROUND

• Murphy CC, Harlan LC, Lund JL, Lynch CF, Geiger AM. Patterns of Colorectal Cancer Care in the United States: 1990-2010. J Natl Cancer Inst. 2015 Jul 23;107(10):djv198. doi: 10.1093/jnci/djv198. Print 2015 Oct.

  PMID: 26206950 BACKGROUND

• Larsson SC, Wolk A. Obesity and colon and rectal cancer risk: a meta-analysis of prospective studies. Am J Clin Nutr. 2007 Sep;86(3):556-65. doi: 10.1093/ajcn/86.3.556.

  PMID: 17823417 BACKGROUND

• Renfro LA, Loupakis F, Adams RA, Seymour MT, Heinemann V, Schmoll HJ, Douillard JY, Hurwitz H, Fuchs CS, Diaz-Rubio E, Porschen R, Tournigand C, Chibaudel B, Falcone A, Tebbutt NC, Punt CJ, Hecht JR, Bokemeyer C, Van Cutsem E, Goldberg RM, Saltz LB, de Gramont A, Sargent DJ, Lenz HJ. Body Mass Index Is Prognostic in Metastatic Colorectal Cancer: Pooled Analysis of Patients From First-Line Clinical Trials in the ARCAD Database. J Clin Oncol. 2016 Jan 10;34(2):144-50. doi: 10.1200/JCO.2015.61.6441. Epub 2015 Oct 26.

  PMID: 26503203 BACKGROUND

• Argiles JM, Busquets S, Stemmler B, Lopez-Soriano FJ. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer. 2014 Nov;14(11):754-62. doi: 10.1038/nrc3829. Epub 2014 Oct 9.

  PMID: 25291291 BACKGROUND

• Tisdale MJ. Cachexia in cancer patients. Nat Rev Cancer. 2002 Nov;2(11):862-71. doi: 10.1038/nrc927. No abstract available.

  PMID: 12415256 BACKGROUND

• Thoresen L, Frykholm G, Lydersen S, Ulveland H, Baracos V, Prado CM, Birdsell L, Falkmer U. Nutritional status, cachexia and survival in patients with advanced colorectal carcinoma. Different assessment criteria for nutritional status provide unequal results. Clin Nutr. 2013 Feb;32(1):65-72. doi: 10.1016/j.clnu.2012.05.009. Epub 2012 Jun 12.

  PMID: 22695408 BACKGROUND

• Petrelli F, Tomasello G, Borgonovo K, Ghidini M, Turati L, Dallera P, Passalacqua R, Sgroi G, Barni S. Prognostic Survival Associated With Left-Sided vs Right-Sided Colon Cancer: A Systematic Review and Meta-analysis. JAMA Oncol. 2017 Feb 1;3(2):211-219. doi: 10.1001/jamaoncol.2016.4227.

  PMID: 27787550 BACKGROUND

• Van Cutsem E, Oliveira J; ESMO Guidelines Working Group. Advanced colorectal cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2009 May;20 Suppl 4:61-3. doi: 10.1093/annonc/mdp130. No abstract available.

  PMID: 19454465 BACKGROUND

• Hochster HS, Grothey A, Hart L, Rowland K, Ansari R, Alberts S, Chowhan N, Ramanathan RK, Keaton M, Hainsworth JD, Childs BH. Improved time to treatment failure with an intermittent oxaliplatin strategy: results of CONcePT. Ann Oncol. 2014 Jun;25(6):1172-8. doi: 10.1093/annonc/mdu107. Epub 2014 Mar 7.

  PMID: 24608198 BACKGROUND

Central Study Contacts

Gehad Abd el-razik, MD

CONTACT

01097381211; dr.gehadahmed95@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 9, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: September 1, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09