Division of Thoracic Surgery / Research

Clinical Research Program

The clinical research program includes research in thoracic oncology, pulmonary hypertension, benign esophageal diseases and lung transplantation. Our research studies include in-house programs in malignant pleural mesothelioma, esophageal cancer, lung cancer, malignant pleural effusions, primary pulmonary hypertension, achalasia and gastroesophageal reflux disease. These include prospective clinical trials,   retrospective studies and translational projects The lung transplantation program includes in- house research, industry funded and multi-institution research.

We participate in cooperative group trials through National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG), American College of Surgeon Oncology Group (ACOSOG) and with our Radiation Oncology Colleagues, the Radiation Therapy Oncology Group (RTOG).

 

Our investigators and their areas of interest include:

 

Dr Tom Waddell:

Neoadjuvant chemotherapy for early stage nonsmall cell lung cancer.
Bone marrow derived lung stem cells
Lung Regeneration
Lung cancer rapid access and management

 

Dr Shaf Keshavjee:

Thymoma
Ex-vivo lung perfusion for assessment of donor lung for
transplantation

                             

Dr Marc De Perrot :

Primary pulmonary hypertension
Malignant Pleural Mesothelioma
Vertebrectomy for T4 nonsmall cell lung cancer

 

Dr Kazu Yasufuku:

Endobronchial ultrasound transbronchial needle aspirate of 
mediastinal lymph nodes for staging of nonsmall cell lung cancer
Early detection of nonsmall cell lung cancer
EBUS-TBNA for assessment of mediastinal abnormalities

 

Dr Gail Darling:

Esophageal cancer
Micro RNA in esophageal cancer
Regionalization of thoracic surgery
Quality of life in esophageal cancer
Symptoms and quality of life in GERD

 

Dr Andrew Pierre:  Use of minimum dose CT in followup for nonsmall cell lung cancer

                               

Our current clinical trials group is composed of 6 Clinical Research Coordinators and 1 Research Clerk.  

Jennifer Lister

Frances Hui (currently on Maternity Leave)

Judy Horneck

Katherine Zeman

Alexandra Salvarrey

Brenda O’Sullivan

Sassan Azad

Karen Roman

 

Our current clinical trials (actively enrolling patients) include:

 

Early Stage NSCLC

  • Surgery for Early Lung Cancer with Preoperative Erlotinib (Tarceva): A Clinical Phase II Trial(SELECT)
  • A Phase III Randomized Trial of Lobectomy Versus Sublobar Resection For Small (≤2cm) Peripheral non-Small Cell Lung Cancer (BRC.5) 

 

Post-Op Studies for NSCLC:

  • Mininimum Dose CTs for Follow-up of Lung Cancer
  • A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB ( >  4 cm) -IIIA Non-Small Cell Lung Cancer (NSCLC)

 
                       
Malignant Pleural Effusions

  • A prospective study of patient centered outcomes in the management of malignant pleural effusions

 

Thymoma

  • Phase II Study of Trimodality Therapy for Patients with Thymoma at Significant Risk of Recurrence

 

Esophageal Cancer

  • A comparison of the FACT-E and EORTC QLQ-C30 in assessing quality of life in patients with esophageal cancer

 

Mesothelioma

  • Phase II Study of Neo-adjuvant Pemetrexed plus Cisplatin followed by Surgery and Radiation Therapy for Malignant Pleural Mesothelioma
  • A Pilot Study Evaluating Short Neoadjuvant Hemithoracic Intensity Modulated Radiation Therapy for Surgically Resectable Malignant Pleural Mesothelioma

 

Lung Transplant

  • Normothermic EX VIVO Lung Perfusion (EVLP) for an Improved Assessment of  Donor Lungs for Transplantation –HELP
  • Bone marrow-derived lung stem cells: Identification and characterization
  • ALN-RSV01-109: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy & Safety of Aerosolized ALN-RSV01 plus Standard of Care in Lung Transplant Patients Infected with Respiratory Syncytial Virus (RSV)-
  • Inflammatory Response to H1N1 (IR-H1N1) Study:Use of XCeed inflammation chip as a predictor for outcome in patients presenting with Influenza like Illness (ILI) to Emergency Room

 

Other Clinical Trials:

  • Adjuvant Sutent Following Chemoradiotherapy and Surgery for Esophageal Cancer, A Phase II Trial (ASSET)
  • Prospective controlled trial of mediastinoscopy compared with endobronchial ultrasound guided transbronchial needle aspiration for assessment of the mediastinum in lung cancer
  • A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non‑small Cell Lung Carcinoma who have EGFR-positive Tumors (RADIANT)
  • Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non-Small Cell Lung Cancer.
  • §  A PHASE III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (IRESSA) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer
  • A Clinical Investigation of Safety and Efficacy of the Novalung Interventional Lung Assist (iLA) System as a Bridge to Lung Transplantation
  • A Multi-center, Randomized, Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation-CYCLIST
  • Serial measurement and clinical relevance analysis of humoral and cellular immunity following lung transplant: a pilot study-MALT
  • A Prospective Patient-Based Analysis of the Epidemiology and Treatment Patterns of Achalasia
  • Does Health Related Quality of Life Predict Choice of Therapy for Reflux Symptoms?
  • Role of Endobroncheal Ultrasound (EBUS) in detecting mediastinum/hilar recurrence of non-small cell lung cancer (NSCLC) after curative resection
  • Esophageal Resection for Cancer, Where Do We Stand?
  • MicroRNA Expression Profiling of Esophageal Cancer
  • Comparison of the Outcome of Patients with Stage IIIa NSCLC with N2 disease Treated with Surgery and Post-Op Radiochemotherapy vs Radiotherapy alone
  • The Effects of Regionalization on Volume and Outcome in Canadian Thoracic Surgical Procedures
  • The Effect of Immunosuppression on Short and Long Term Outcomes for Lung Cancer Surgery
  • Clinical Outcomes of Patients with Resected Metachronous Lung Cancer
  • Outcome after pulmonary metastasectomy for colon carcinoma
  • Genetic alterations in samples obtained by mediastinoscopy
  • A Comparison of VATS vs. Open Lobectomy in Resected Non-Small Cell Lung Cancer

 

Education: About Clinical Trials

Clinical Trials at UHN

What You Need To Know…

A Guide for Patients, Their Families and Friends 
 

Patients at UHN may be asked if they would like to be involved in a clinical trial during their time at the hospital. The staff at UHN has created this brochure in order to provide patients, their families and friends with some basic information about clinical trials. Participating in a clinical trial is always voluntary.

Index

What is a Clinical Trial?

Why Clinical Trials are done

How a Clinical Trial is Started

How a Clinical Trial is Run

Frequently Asked Questions

What are the Research Team’s Responsibilities?

What is a placebo?

What do they mean by ‘randomized’?

What about Side Effects?

What if I don’t want to be in the study, is my Doctor 
going to be upset?

 

 

What is a Clinical Trial?

A clinical trial is a type of research study that is done to help learn about new ways to prevent, diagnose or treat a disease. This type of research involves human beings who choose to participate. There are different types of clinical trials. Some types of clinical trials that occur at UHN include:

  • Prevention Trials: The goal of these studies is to prevent a disease or condition
  • Diagnostic Trials: The goal of these studies is to better detect an existing disease or condition. Diagnostic studies may also look at detecting a risk of developing a disease or condition.
  • Treatment Trials: The goal of these studies is to find better ways to treat a disease or condition.
  • Quality of Life Trials: The goal of these studies is to see how patients are feeling.

 

Why Clinical Trials are done?

 

To improve medicine

Clinical Trials are one of the last stages of cancer research. Before a clinical trial is started, a lot of promising research has already occurred.  Research that shows promise must first be tested in a clinical trial before it can be used in everyday medicine, or as the standard of care.

 

To provide patients with an other option

For patients, clinical trials offer one more choice in their medical care.

Sometimes, patients who participate in clinical trials will have access to treatments and procedures that otherwise would not be available. However, it is important to understand what is involved in a clinical trial before deciding to participate.

 

How a Clinical Trial is Started

Designing the clinical trial

Once it has been decided that a clinical trial is needed, a team of researchers will write a protocol.

The protocol is like a recipe for the research team. 
It tells them why, when and how different parts of the study are to be done.

 

Approving the Clinical Trial

All clinical trials must be approved by a Research Ethics Board before any patient is approached about the study.

A Research Ethics Board is a group of individuals with different professional backgrounds that review all clinical trials to make sure that patients’ rights are protected.

Health Canada also has to approve certain clinical trials, such as any clinical trial that is using an investigational product.

An Investigational Product is a medication, agent or device that is not yet on the market.

Only approved clinical trials can be carried out at this hospital. Approved clinical trials may or may not be beneficial to the clinical trial patients and approval does not guarantee that there are no risks involved with the clinical trial.

 

How a Clinical Trial is Run

At this hospital, a doctor leads a clinical trial. There is always one main doctor that is responsible for the trial. This person is called the Principal Investigator. There are also other doctors and researchers that work with the Principle Investigator and they are called theCo-Investigators. Clinical Research Coordinators work with the doctors and the researchers to help organize and run the study and to help care for the clinical trial patients.

 

Clinical Trials are made up of different stages. The main stages for most clinical trials are:

•     The Informed Consent Process

•     Screening Stage

•     Active Stage

•     Withdrawal Stage

•     Follow-up Stage

 

The Informed Consent Process

The informed consent process involves the sharing of information about the clinical trial between the patient and clinical research team. This process starts from the moment that a patient is first approached about participating in a clinical trial, and continues throughout the study.

Patients are given information from many sources. The doctor and research staff will talk to the patient about the trial, and will answer any questions that they might have.

Also, a document called the Informed Consent Form will be given to the patient. This form provides a lot of information, and if the patient decides to participate in the study they will be asked to sign this form. Patients will be provided with a copy of the informed consent form for their records.

During the study, any new information about the clinical trial will be shared with the clinical trial patient.

 

Screening Stage

Not all clinical trials are right for everyone. The study protocol outlines what characteristics a patient must have to be involved in a clinical trial.

The screening stage is the process involved to determining if the patient is eligible to be involved in the clinical trial. This process may involve extra tests or procedures.

 

Active Stage

If a patient is found to be eligible for a clinical trial during the screening stage they can begin the active stage of the clinical trial. The active stage is when the clinical trial patient receives the treatment, agent, or procedure being tested.

 

Withdrawal Stage

The withdrawal stage is when the final information is collected about the patients experience during the active phase. This stage starts when the active stage is stopped.

 

Follow-up Stage

Some clinical trials will have a follow-up phase. Follow-up is when the research team will continue to check a patient’s medical progress after they have finished the active and withdrawal phase of a clinical trial. Follow-up allows doctors and scientists to see the long-term outcome of the clinical trial.

 

Frequently Asked Questions

What Would My Responsibilities Be?

Extra Tests, Procedures and Time

Clinical Trials may involve extra tests, procedures and visits to the hospital. The informed consent form will explain what additional tests, procedures and visits should be expected. The additional tests, procedures and visits will often have to occur at specific times throughout the study. 

Communication

It is very important for clinical trial patients to communicate with their research team. The research team will collect a lot of information each time a clinical trial patient is in for a visit. It is also important that the clinical trial patient continues to communicate with the research team between study visits.

 

Some of the information that the research team will want to know include:

  • Medical History
  • Changes in medications. The research team will ask for the name, the dose, what the medication is for and when the change happened. It is important for the study team to know everything that a clinical trial patient is taking, even if it is not a prescription medication.
  •  Changes in health (positive and negative). The research team will ask when the changes started and stopped and how the clinical trial patient is managing.
  • Continued Study Involvement. If the clinical trial patient decides that they want to stop being involved in the clinical trial, they need to notify the research team.

 

What are the Research Team’s Responsibilities?

All medical professionals involved in clinical research, and all clinical research staff must follow certain professional guidelines called the Guidelines for Good Clinical Practice. These guidelines help protect the rights, safety and well being of clinical trial patients.

The research team has certain responsibilities to clinical trial patients. 
These responsibilities include:

  • Informing the Clinical Trial Patient: Clinical trial patients have the right to receive information that may change their decision to be involved in a clinical trial.
  • Freedom of Choice for the Patient: The research team has a responsibility to make sure that a patient’s choice to be involved in a clinical trial is voluntary and that they do not feel pressured to participate.
  • Respect for the Patient: The research team has a responsibility to respect the privacy, confidentiality and the decisions of the clinical trial patient.
  •  Be Qualified: The research team has a responsibility to be qualified to run the clinical trial and to care for the clinical trial patients.

 

What is a placebo?

A placebo is sometimes referred to as a ‘sugar pill’. It is a product that has been created to look like a type of medication or agent but that does not contain the ingredient that is responsible for the effect of the medication or agent.

 

Are placebos used in all studies?

No. Placebos are not used in all clinical trials.

There are only certain types of clinical trials that are allowed to use a placebo:

  • When there is no proven treatment available for a group of patients. In this case, taking a placebo is similar to receiving the standard treatment.
  • When a condition being treated is not severe and the use of a placebo will not cause increased harm to the patient.

 

Why are placebos used in clinical trials?

Placebos allow researchers to see if a medication or agent is actually working, or if the trial results are just by chance.

What if there is an emergency and a doctor needs to know what medication I am on?

If ever there was an emergency, the research team is able to find out whether the clinical trial patient was taking the placebo or the study medication. 

 

What do they mean by ‘randomized’?

Randomization assigns patients into a treatment group by chance. The research team is not involved in deciding what type of treatment the patient is going to receive during the clinical trial.

 

Do all clinical trials use Randomization?

No. Not all clinical trials are randomized. Clinical trials that have more than one treatment group may use randomization to decide which treatment a patient will receive.

 

Why is randomization used in clinical trials?

Randomization is used in clinical trials to make sure that all patients are treated equally. Randomization ensures that all patients have the same chance of being on any of the treatment groups in the study.

 

What about Side Effects?

How will I know what side effects could happen?

The Informed Consent Form will list the side effects, or adverse events, that may happen while on the clinical trial and what the chance is of experiencing the events listed. Patients are given this information before they decide to get involved in the clinical trial and they are also informed if there is a change to this information. 

 

Are these the only side effects that I could have?

No. Unexpected side effects can happen during the clinical trial. The Informed Consent Form will list the adverse events that are known, but that does not mean that other adverse events could not happen.

 

What happens if I have a side effect?

If a clinical trial patient experiences a side effect while on a clinical trial, they will receive the necessary medical attention needed.

 

What if I don’t want to be in the study, is my Doctor going to be upset?

No. Doctors and research teams want to make sure that patients are told about clinical trials, because it is a treatment option, but they are very understanding of a patient’s right to decide. Even if a patient chooses to be involved in a clinical trial, they can always change their mind and this decision will not negatively affect their medical care at the hospital. This is one of the rights of a research patient.

 

Useful Links

  • Ontario Cancer Trials Website: This website includes a database of cancer clinical trials inOntario that patients, their families and friends can search. There is also general information about clinical trials on this website. The website is http://ontariocancertrials.ca
  • Canadian Cancer Society: The Canadian Cancer Society can provide patients, their families and friends with information about cancer and cancer research. The society has a website at www.cancer.ca. They can also be reached at 1-888-939-3333.
  • National Institutes of Health: This website includes a database of clinical trials that are running for many diseases and conditions. This database includes clinical trials that are running across North America and parts of Europe. The website is www.clinicaltrials.gov
  • Health Canada: The Health Canada website has information about different drugs and health products.  This includes information about how clinical trials are regulated inCanada. The website is www.hc-sc.gc.ca.

 

 

 

 

 

 

 

 

 

 

 

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