Colorectal Cancer

About Colorectal Cancer Clinical Trials (Click to Open)

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General Purpose:

Colorectal Cancer Clinical TrialsAlthough colon cancer and rectal cancer are two distinct types of cancer, they are frequently discussed as one, using the term “colorectal cancer.” Therefore, it is important to keep in mind that the term “colorectal cancer” actually refers to both colon and rectal cancer. This article focuses on Colorectal cancer clinical trials.

Colorectal cancer will affect nearly 150,000 individuals in the United States in 2012, and is estimated to result in over 50,000 deaths. Its widespread prevalence has driven research efforts in recent years to focus on gaining a better understanding of how colon cancer develops, how it can be prevented, and the most effective ways of treating it.

Current research is investigating the use of various medications to prevent colorectal cancer in individuals who are considered “high risk,” such as those who have precancerous polyps in their colon or those who have a family history of the disease. Along those lines, researchers are also working to better understand the genetic profile of colorectal cancer and identify specific genes and family cancer syndromes that increase an individual’s risk of developing colorectal cancer.

Such research may lead to the development of new and improved genetic screening methods. Moreover, new drugs to treat colorectal cancer are constantly being evaluated in clinical trials, as are new surgical treatments and other therapeutic options.

What Will Colorectal Cancer Clinical Trials Be Like?

Clinical trials for colorectal cancer may involve many common tests and procedures; however, the ultimate design of the particular study will determine which specific procedures you will undergo. The following tests and procedures are often used during Colorectal Cancer Clinical Trialscolorectal cancer clinical trials:

  • Physical exam and detailed family history information.
  • Digital rectal exam (DRE)
  • Polypectomy (removal of non-cancerous polyps in the colon)
  • Blood and/or tissue sample for the purposes of conducting genetic testing.
  • If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
  • Food diary to track dietary intake over an extended period of time.
  • Fecal occult blood test (FOBT) to check for hidden blood in fecal matter.
  • Sigmoidoscopy, which is a procedure during which the rectum and lower colon are examined using a thin, flexible tube with a tiny light and camera on the end.
  • Colonoscopy, which is a procedure similar to a sigmoidoscopy, however it is used to view the entire colon.
  • Double contrast barium enema (DCBE). This procedure involves taking a series of x-rays after the patient is given a barium-containing enema and air is introduced into the colon to make it more visible.
  • Imaging procedures such as computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.        
  • Biopsy

Typical Colorectal Cancer Clinical Trial Protocol:

There is a variety of research currently being conducted for patients with colorectal Colorectal Cancer Clinical Trialscancer. Sample colorectal cancer clinical trials might include the following:

  • A clinical trial in which standard chemotherapy plus a new drug that targets certain growth-promoting factors within cancer cells is compared to standard chemotherapy alone.
  • A long-term clinical trial designed to evaluate if a new chemotherapy drug is more effective at reducing the risk of colorectal cancer recurrence than standard chemotherapy.
  • A study to evaluate if colorectal cancers with certain genetic mutations respond more favorably to a particular chemotherapy drug than colorectal cancers without those same genetic mutations.
  • A long-term study designed to evaluate if major dietary changes can lower the risk of developing colon cancer in high-risk individuals.
  • A clinical trial to determine if long-term consumption of high dose aspirin reduces the risk of colorectal cancer among high-risk individuals.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug Colorectal Cancer Clinical Trialscompared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:

  • The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

Suggested Search Terms:

When embarking on your search for clinical trials related to colorectal cancer, be sure to remember that “colorectal” actually refers to both the colon and the rectum. Therefore, unless you have been diagnosed with cancer of the colon and rectum, your search is likely to be most successful if you tailor it to include your specific diagnosis.

Once you are ready to begin your search for colon or rectal cancer clinical trials, adding the following terms to “colon cancer” or “rectal cancer” (depending on your diagnosis) will likely produce the most relevant findings:”Colorectal cancer clinical trials,” “screening,” “treatment,” “metastatic,” “chemotherapy,” “treatment,” “prevention,” “family history,” “nutrition,” “diet,” and “surgery.”

Current Search Term:

“Colorectal Cancer”

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Systemic Screening for Hereditary Colorectal Cancer in China

Condition:   Hereditary Colorectal Cancer
Intervention:   Diagnostic Test: genetic screening
Sponsor:   Sun Yat-sen University

A Study of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Metastatic Colorectal Cancer

Condition:   Metastatic Colorectal Cancer
Interventions:   Biological: CPGJ602;   Biological: Cetuximab
Sponsor:   Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28

Condition:   Colorectal Cancer
Intervention:   Drug: Irinotecan
Sponsor:   Shanghai Changzheng Hospital

Study of TAS-102 Plus Radiation Therapy for the Treatment of the Liver in Patients With Hepatic Metastases From Colorectal Cancer

Condition:   Colorectal Cancer
Interventions:   Drug: TAS-102;   Radiation: Photon SBRT
Sponsors:   Massachusetts General Hospital;   Taiho Oncology, Inc.

Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing

Condition:   Colorectal Cancer
Interventions:   Behavioral: Interview;   Behavioral: Questionnaire
Sponsors:   M.D. Anderson Cancer Center;   Patient-Centered Outcomes Research Institute

A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer

Condition:   Colorectal Cancer Metastatic
Intervention:   Drug: Lamivudine
Sponsor:   Massachusetts General Hospital

Enhanced Recovery After Surgery Program for Colorectal Cancer: a Multi-center Study (ERASC1)

Condition:   Colorectal Cancer
Intervention:   Procedure: enhanced recovery after surgery
Sponsor:   Jinling Hospital, China

LEAC-102 for Advanced Colorectal Cancer

Condition:   Advanced Colorectal Cancer
Intervention:   Drug: LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab
Sponsor:   Taiwan Leader Biotech Corp.
Not yet recruiting

Clinical Study of Safety and Tolerability of CBLB502 as a Neo-adjuvant Treatment in Patients With Colorectal Cancer

Condition:   Colorectal Cancer
Interventions:   Drug: CBLB502;   Drug: Placebo
Sponsors:   BioLab 612 LLC;   Cleveland BioLabs, Inc.
Active, not recruiting

Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer

Condition:   Metastatic Colorectal Cancer
Intervention:   Drug: TAS-102 and Bevacizumab
Sponsor:   Georgetown University

A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer

Condition:   Metastatic Colorectal Cancer
Interventions:   Drug: BBI608;   Drug: 5-FU;   Drug: Irinotecan;   Drug: Levofolinate;   Drug: Bevacizumab
Sponsor:   Sumitomo Dainippon Pharma Co., Ltd.

A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer

Condition:   Colorectal Cancer
Intervention:   Drug: panitumumab, TAS-102
Sponsor:   Takeda
Active, not recruiting

Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

Condition:   Metastatic Colorectal Cancer
Interventions:   Drug: Sym004;   Drug: Irinotecan;   Drug: Folinic Acid;   Drug: Fluorouracil
Sponsor:   Symphogen A/S
Active, not recruiting

Drug Trial to Investigate the Safety and Efficacy of Niclosamide Tablets in Patients With Metastases of a Colorectal Cancer Progressing After Therapy

Condition:   Colorectal Cancer
Intervention:   Drug: Niclosamide
Sponsors:   Charite University, Berlin, Germany;   Center for Molecular Medicine

Regorafenib in Metastatic Colorectal Cancer

Condition:   Metastatic Colorectal Cancer
Intervention:   Drug: Regorafenib
Sponsors:   University of Rochester;   Bayer

ASPirin Intervention for the REDuction of Colorectal Cancer Risk

Condition:   Colorectal Cancer
Interventions:   Drug: Aspirin;   Drug: Placebo for Aspirin
Sponsors:   Massachusetts General Hospital;   National Cancer Institute (NCI)
Enrolling by invitation

An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus. mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer.

Condition:   Colorectal Cancer
Interventions:   Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab;   Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
Sponsor:   Takeda
Active, not recruiting

ColoCare Study - Colorectal Cancer Cohort

Condition:   Colorectal Cancer
Sponsors:   University of Utah;   German Cancer Research Center;   H. Lee Moffitt Cancer Center and Research Institute;   Huntsman Cancer Institute;   Cedars-Sinai Medical Center;   Washington University School of Medicine;   University of Tennessee

A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients (FRESCO)

Condition:   Colorectal Cancer
Interventions:   Drug: fruquintinib;   Drug: placebo
Sponsors:   Hutchison Medipharma Limited;   Fudan University;   Eighty-One Hospital of People's Liberation Army

Prognostic Value of Tissue Factor (TF) in Blood t in Colorectal Cancer in Adults

Condition:   Colorectal Cancer
Interventions:   Biological: Group CRC;   Biological: Group control
Sponsor:   University Hospital, Lille

Role of the MET Oncogene in Human Colorectal Cancer - A Translational Study

Condition:   Colorectal Cancer
Sponsor:   Fondazione del Piemonte per l'Oncologia

A Phase II Study of Ziv-aflibercept in Combination With Capecitabine/Oxaliplatin (XELOX) Chemotherapy in the Front-Line Treatment of Patients With Metastatic Colorectal Cancer

Condition:   Metastatic Colorectal Cancer
Interventions:   Drug: Arm A;   Drug: Arm B
Sponsors:   James J Lee;   Sanofi

Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases

Condition:   Colorectal Cancer Metastatic
Interventions:   Drug: Raltitrexed;   Drug: Oxaliplatin;   Drug: lipiodol
Sponsor:   Nanjing Chia-tai Tianqing Pharmaceutical

Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

Condition:   Colorectal Cancer
Interventions:   Drug: LGX818;   Drug: Cetuximab;   Drug: BYL719
Sponsor:   Array BioPharma
Active, not recruiting

Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies

Condition:   Colorectal Cancer
Interventions:   Drug: TAS-102;   Drug: Placebo
Sponsor:   Taiho Oncology, Inc.

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