Clinical Trials Matter!

If you are interested in a clinical trial or if your team feels there is a trial that may be right for you, we will arrange an appointment with one of the researchers conducting the trial with your permission.

Sometimes, your oncologist may also be the doctor in charge of the trial. You may also meet with a Clinical Trial Research Nurse (CTRN) or Clinical Research Associate (CRA) at one of your scheduled appointments.
 

Someone from the research team will review the clinical trial with you and answer any questions. They will also review the informed consent form with you. You do not have to agree to participate right away or at all. Please take as much time as you need to think about your decision and discuss your thoughts with others. Another appointment may be booked to talk about the trial further.
 

If you choose to participate, there are several steps to taking part in clinical trial which will be discussed with you. Our dedicated team will help you through these steps and will become your main contact throughout the trial. You do not have to stay in a trial if you do not wish to.

Open for Recruitment

(Novartis) CNIS793E12201 NCT04952753

Description: daNIS-3: An open-label, multi-center, phase II platform study evaluating the efficiency and safety of NIS793 and other new investigational drug combinations with standard of care(SOC) anti-cancer therapy for the second line treatment of metastatic colorectal cancer(mCRC)

Principle Investigator: Dr. Anupam Batra 

Open to Recruitment

(CCTG)CRC.9/NRG-GI005 Study NCT04068103

Description: Phase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Stage IIA Colon Cancer(COBRA)

Principle Investigator: Dr. Anupam Batra

Open to Recruitment

Expression of Interest

(CCTG) CRC.10/NRG GI-008 NCT05174169

Description: Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease(CIRCULATE-US)

Principle Investigator: Dr. Anupam Batra

Expression of Interest

CCTG) BLC.5/Alliance A032001 NCT05092958

Description: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab after Frist-Line Platinum-Based Chemotherapy in Patients with Metastatic Urothelial Cancer

Principle Investigator: Dr. Anupam Batra 

Expression of Interest

Closed for Recruitment

(CCTG)GCC.1/SWOG S1823 NCT04435756

Description: A Prospective observational Cohort Study to Assess miRNA 371 for Outcome prediction in Patients with Newly Diagnosed Germ Cell TumoursDr. Anupam BatraOpen to recruitment(CCTG)CO.29/DYNAMIC III Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomized Controlled Study(Dynamic-III)

Principle Investigator: Dr. Anupam Batra

Closed to recruitment

(Novartis) CNIS793B12301 NCT04935359

Description: daNIS-2: A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitibine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma(mPDAC)

Principle Investigator: Dr. Anupam Batra 

Closed to Recruitment

(CCTG)BR.34  NCT03057106

Description: Randomized Trial of Durvalumab and Tremelimumab +- Platinum-Based Chemotherapy in Patients with Metastatic(Stage IV) Squamous or Non-Squamous Non-Small cell Lung Cancer (NCLSC)

Principle Investigator: Dr. Anupam Batra

Closed to Recruitment

(NCIC CTG) PR.17 NCT02446405

Description: Randomized Phase 3 Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

Principle Investigator: Dr. Anupam Batra 

Closed to Recruitment

(Novartis)CLEE011A2207 NCT03822468

Description: A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of 400mg of ribociclib in combination with non-steroidal aromatase inhibitors for the treatment of pre and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received no prior therapy for advanced disease

Principle Investigator: Dr. Anupam Batra

Closed to Recruitment

(Novartis) Non-Interventional Study: Treat ER+ Right NCT02753686

Description: Treatment of Canadian Men and Pre/Post Menopausal Women with ER+ Advanced Breast Cancer in the Real-World Setting with Hormone Therapy +- Targeted Therapy

Principle Investigator: Dr. Helen Lin

Closed to Recruitment

(CCTG)MAC.20/Alliance A011401/BWEL Study NCT02750826

Description: Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer

Principle Investigator: Dr. Anupam Batra

Closed to Recruitment

(CCTG)MAC.21/Alliance A011502 Study NCT02927249

Description: Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

Principle Investigator: Dr. Anupam Batra

Closed to Recruitment

Informed consent includes discussing, reading and understanding the clinical trial. You must sign an informed consent form in order to participate in trial.

Informed consent includes talking about why the trial is being done, who is involved, how long the trial will be, how many patients will be involved, risks and benefits, your legal rights, what you can expect from the trial (screening, tests, your appointments, possible side effects, follow-ups, costs), how the information is collected, how we will protect your privacy, and how you will receive updates about the trial.

By signing the informed consent form, you indicate that you understand all of the information you have been given. You can change your mind at any time for any reason. A copy of the signed consent form is given to you to keep. Once you sign the informed consent form, you will be screened to see if you are eligible for the trial.

Informed consent is a constant process. You are encouraged to ask questions and whenever new information about the clinical trial is known we will share it with you.

It is common that the consent form updates occur throughout a study. If there is a consent update while you are participating in a clinical trial, you will be presented with this updated information to review.

Many clinical trials include the collection of blood and tissue samples for medical research. These are called biospecimens. Medical researchers use your samples along with samples from thousands of other patients to look for ways to prevent, find, or treat health problems like cancer, diabetes, heart disease. Many people find comfort knowing that by donating samples, they will help researchers make discoveries that can advance medicine and improve the treatment of others in their community. These samples are usually stored within Canada or the USA. To protect your privacy, your samples will be coded with a random number instead of your name and any identifiers will be removed before the sample is sent to the biobank research facility. Federal law requires the protection of your private medical information.

Every trial has eligibility criteria which determines who can and cannot participate in a trial. This is to protect your safety. You may be asked to undergo certain tests, procedures, or blood work to determine if this trial is right for you.

There are many types of clinical trials. Your research team will follow strict rules outlined in the clinical trial protocol when giving the trial treatments or interventions. 

Intervention: In a clinical trial that uses an intervention, such as testing different cancer scanning techniques, the goal is usually to prevent cancer, detect cancer earlier or improve the management of symptoms. 

Treatment: Other clinical trials may test different treatments. The goal of treatment is to get rid of, stop, slow, or reduce the growth of your cancer. In these clinical trials, your research team will watch you and your cancer closely to see if the treatment is working and to manage any side effects. In some trials, there is a prescribed number or amount of treatment given; in others, you may stay on the treatment as long as it is benefitting you. If the treatment is not working for you, meaning your cancer is growing, the trial treatment will be stopped and other treatment options will be discussed with you.

Treatment can be stopped for various reasons, such as if your cancer does not respond to treatment, or you are having side effects that cannot be easily managed, or if it is no longer in your best interest to be on that particular treatment (such as if there’s a better treatment available for you). You can choose to stop participating in a trial at any time as well.

When the trial treatment or intervention is completed or stopped, you enter the follow-up stage of the clinical trial. You may be asked to complete tests, procedures, bloodwork, or assessments in order to measure the trial.

After you are finished in the trial, you may be asked for further tests or assessments. Follow-up may be done by appointment, over the phone, or even by looking at your medical records (which may not require any action on your part).

Once all patients have had their follow-up completed, the study results are analyzed.

Most trials will look at their data while the study is on-going, which is called an “interim analysis”. This helps determine if the trial is working, and if so, the trial will continue.

At the end of the trial, the final results are reviewed, analyzed, presented, and published. As a participant, you may be given the results of the study. If the new treatment is proven safe and effective, further testing may occur or Health Canada may review and approve the treatment for wider use.

Clinical trials are always changing the standard of care to bring new and better treatments to the forefront.

All clinical trials need ethics approval. This is to protect the health, safety, and privacy of everyone who participates in the trial. Trials at Cambridge Memorial Hospital are approved by either our local regional Waterloo Wellington Research Ethics Boards (WWREB) or by the Ontario Clinical Trial Research Ethics Boards (OCREB).

CMH's Oncology Program has been involved in Clinical Trials for over 25 years. Our accomplishments include:

• Top enroling Canadian Site for the Novartis AMALEE Breast Cancer Study
• Top enroling Canadian site for the Novartis Bolero 1 Breast Cancer study
• Second top enroling Canadian site for the BNIT Prostvac Metastatic Prostate Cancer study

These National resources offer reliable information about clinical trials that are open to recruitment:

• Ontario Cancer Research Ethics Board (OCREB)
  OCREB works with researchers, institutions, and sponsors to protect the rights and welfare of trial participants in Ontario while advancing ethically sound cancer research.
   

• Canadian Cancer Trials
  Clinical trials in all Canadian provinces.

   

• Canadian Clinical Trials Group
  The Canadian Cancer Trials Group is a cancer research cooperative group that designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. Primary support for the Canadian Cancer Trials Group comes from the Canadian Cancer Society.
   
• Canadian Cancer Society
  Access online or call toll-free 1-888-939-3333
   
• It Starts with Me
  A website about clinical trials developed by patients and caregivers who have participated in a clinical trial or have had a loved one participate in a clinical trial and by people who work in clinical trials and research. The website tells you everything you need to know about clinical trials, things to think about or ask before you decide to participate, and your rights as a person who is volunteering in a clinical trial. There is also a glossary of terms for you. The site was created by the Network of Networks (N2) - an organization that represents organizations that do clinical research and trials in Canada

• The National Cancer Institute
  Provides accurate up-to-date information about many types of cancer, clinical trials, information for researchers and health professionals, and resources for people dealing with cancer
   
• U.S. National Library of Medicine: Clinical Trials
  Provide patient, families, and the public with easy and free access to information about clinical trials for a wide range of conditions and diseases