AzTrials
AzTrials

Colorectal Cancer MetastaticNCT04543019

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

An observational study of Colorectal Cancer Metastatic, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
How many people
50 participants
Where
No sites listed yet
Study dates
Dec 2020to Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Gehad Abd el-razik, MD contact

01097381211

dr.gehadahmed95@gmail.com

About this study

Official title: Age, Body Mass Index and Tumor Sidedness in Metastatic Colorectal Cancer Patients as Predictive Factors for Systemic Therapy Outcome

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.

Read the detailed description

Colorectal cancer (CRC) represents a major public health concern as it is the third most frequently diagnosed cancer and the fourth cause of cancer-related mortality worldwide . The five-year survival rate is around 64.9% for all stages, while in metastatic cases, it only reaches 13.1% .

Approximately 26% of CRCs are diagnosed at stage IV among patients aged younger than 50 years, compared with 23% in those aged 50 to 64 years and 19% among those aged 65 years and older. Overall survival (OS) among patients younger than 50 years (68%) is similar to that in those 50 to 64 years (69%) because of a later stage at diagnosis.

Obesity is associated with an increased incidence of CRC . In recent studies body mass index (BMI) was prognostic for overall survival and progression free survival. That is risk of progression and/or death was greatest for low BMI; risk decreased as BMI increased. BMI was not predictive of treatment effect . Cachexia and associated poor performance status have previously been identified as negative prognostic factors in patients with CRC.

Tumor sidedness is an independent prognostic factor in patients with early and metastatic CRC as left-sided primaries have improved outcomes. sidedness also represents a powerful predictor of benefit from anti epidermal growth factor receptor[EGFR] inhibitors therapies in patients with RAS wild-type metastatic CRC (mCRC) .

The mainstay of treatment of mCRC includes cytotoxic chemotherapy with the addition of a molecularly targeted agent . The cytotoxic regimens that are usually used include a combination of oxaliplatin or irinotecan with a fluoropyrimidine, in addition to targeted agents such as [EGFR] inhibitors for patients with RAS wild-type mCRC or vascular endothelial growth factor inhibitors .

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: between January 2015 and December 2019

Secondary outcomes (1)

  1. response to systemic therapy

    response to systemic therapy in correlation to age, BMI and tumor sidedness

    Measured: between January 2015 and December 2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study startDec 2020 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04543019
Sponsor's protocol ID
systemic therapy in mCRC
Status last verified
Sep 2020
First submitted
20 Aug 2020
Last updated
16 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29155929

  • 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.

    PubMed 26553611

  • 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.

    PubMed 24078664

  • 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.

    PubMed 26206950

  • 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.

    PubMed 17823417

  • 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.

    PubMed 26503203

  • 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.

    PubMed 25291291

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

    PubMed 12415256

  • 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.

    PubMed 22695408

  • 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.

    PubMed 27787550

  • 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.

    PubMed 19454465

  • 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.

    PubMed 24608198

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer Metastatic, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gehad Abd el-razik, MD (01097381211, dr.gehadahmed95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) and overall survival (OS) (time frame: between January 2015 and December 2019). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04543019, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.

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