REaCT
REthinking Clinical Trials

Studies

REaCT studies typically focus on comparing commonly-used treatments, rather than testing new treatments. They are designed so that a wide range of people with cancer can easily participate without the need for extra tests, hospital visits or lengthy consent forms. Data are typically gathered in real-time from electronic medical records and through quality of life surveys. By simplifying the process, REaCT trials can involve more patients and produce results that more accurately reflect the patient population. REaCT trials also have economic evaluation embedded to ensure evaluation of value to both patients and the health care system.

How do I participate?

Patients who are interested in learning more about a REaCT trial should speak with their primary care physician.

All REaCT studies are registered on a public registry (www.ClinicalTrials.gov) which lists all study details including criteria for participation, treatments being compared, current status of the study, and contact information for the principal investigator.

REaCT-NSQIP

Oral antibiotics (pre-treatment vs no treatment) in colorectal surgery Principal

Principal Investigator(s): Dr. Rebecca Auer

ClinicalTrials.gov: NCT03663504
The divergence of clinical practice guidelines, in addition to observation from the large North American retrospective studies, suggest that surgeons and centers have not established a standard of care for the preoperative preparation of the bowel prior to colorectal surgery. Multiple trials have demonstrated that the use of mechanical bowel preparation (MBP) has been associated with no reduction and possibly an increase in surgical infections but that MBP plus oral antibiotics are superior to MBP alone.  In this study, we hypothesize that it is the oral antibiotics, and not the MBP, that is responsible for the reduction in postoperative infectious surgical complications in patients undergoing elective colorectal resections.

Sites: Mount Sinai Cancer Centre The Ottawa Hospital Toronto Western (UHN)

Tags: Colon cancer Surgery

Publications:

Study Protocol:

  • Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol. Apte et al, 2020. PMID: 32647023
REaCT-RETT

Concurrent radiation + endocrine therapy vs sequential radiation + endrocrine therapy

Principal Investigator(s): Dr. Jean-Marc Bourque and Dr. Sharon McGee

ClinicalTrials.gov: NCT03948568
After breast cancer surgery, patients receive either concurrent or sequential endocrine and radiation therapy, where concurrent therapy consists of endocrine therapy started before, with or during radiotherapy, while sequential treatment is defined as endocrine therapy starting after the completion of radiotherapy. This randomized clinical trial investigating the timing of adjuvant radiation and endocrine therapy in patients with early-stage breast cancer. Although these are established treatments received by a large proportion of breast cancer patients, the optimal timing remains unclear. This trial is comparing endocrine therapy given alongside, or following completion of, adjuvant radiotherapy, with key endpoints being endocrine therapy tolerance, and compliance.

Sites: Lakeridge Health (Oshawa) Markham Stouffville Hospital The Ottawa Hospital

Tags: Early stage Breast Cancer

Publications:

Systematic Review:

  • Optimal sequence of adjuvant endocrine and radiation therapy in early-stage breast cancer – A systematic review. McGee et al, 2019. PMID: 30014951

Physician Survey:

  • Physician Survey of Timing of Adjuvant Endocrine Therapy Relative to Radiotherapy in Early Stage Breast Cancer Patients. McGee et al, 2019. PMID: 30318304
REaCT-Low Risk HER2

Comparing two chemotherapy treatments (TC-Herceptin vs weekly Paclitaxel + Herceptin) for low risk HER2 positive, early stage breast cancer.

Principal Investigator(s): Dr. Terry Ng

ClinicalTrials.gov: NCT03705429
In a real-world population with either lower risk breast cancer or increased frailty (older patients, co-morbidities), assessing the relative benefits and toxicity of a chosen chemotherapy regimen is essential. This study compares TC-H chemotherapy with weekly P-H chemotherapy in low risk patients and will provide us with more information regarding cost-effectiveness, toxicity, quality of life, patient reported outcomes and clinical benefits of the two strategies.

Sites: London Health Sciences Centre The Ottawa Hospital

Tags: Early stage Breast Cancer

Publications:

  • Survey: In progress
REaCT-Algorithm

Observing Oncotype DX ordering behaviour at 6 Ontario sites

Principal Investigator(s): Dr. Arif Awan

ClinicalTrials.gov: NCT04131933
Only some patients with early-stage hormone receptor positive breast cancer benefit from chemotherapy which can have some significant side effects. Patients and clinicians rely on the classic factors such as patient’s tumor size, grade, age in a publicly available tool called PREDICT 2.1 as well as newer and expensive genomic tests looking at patient’s cancer genetic make-up to decide whether there’s a substantial benefit of chemotherapy. In this trial we are assessing how clinicians use PREDICT 2.1 and the genomic tests in their practice with patients to guide decision-making around adjuvant chemotherapy.

Sites: Cancer Centre of Southeastern Ontario (Kingston) Grand River Hospital (Kitchener Waterloo) Markham Stouffville Hospital The Ottawa Hospital Thunder Bay Regional Health Sciences Centre Windsor Regional Hospital

Tags: Early stage Breast Cancer

Publications:

Previous Trial and Economic Analysis:

  • Does integration of Magee equations into routine clinical practice affect whether oncologists order the Oncotype DX test? A prospective randomized trial. Robertson et all, 2019. PMID: 30672056
  • Cost analysis of using Magee scores as a surrogate of Oncotype DX for adjuvant treatment decisions in women with early breast cancer. De Lima et al, 2019. PMID: 31287198
  • Selecting Patients for Oncotype DX Testing Using Standard Clinicopathologic Information. Robertson et al, 2019. PMID: 31551182
REaCT-HOLD BMA

De-escalating BMA treatment after two years vs continuing

Principal Investigator(s): Dr. Terry Ng

ClinicalTrials.gov: NCT04549207
While informal surveys of oncologists and patients have suggested that they would not want to discontinue BMA therapy entirely after 2 years of treatment, they are interested in de-escalating to treatment every 24 weeks, and this de-escalated interval is supported by data from the osteoporosis population. Indeed, clinical experience shows that many oncologists already further de-escalate and sometime stop prescriping BMAs in patients who have been on these agents for several years. This study is the first pragmatic, multicentre, open-label, randomized clinical trial to evaluate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and metastatic castration-resistant prostate cancer.

Sites: The Ottawa Hospital

Tags: Castration-resistant prostate cancer Metastatic breast cancer

Publications:

Systematic Review:

  • Long-term impact of bone-modifying agents for the treatment of bone metastases: a systematic review. Ng et al, 2020. PMID: 32535678
REaCT-Hot Flashes survey

Patient survey for patients with early stage breast cancer, that have experienced hot flashes.

Principal Investigator(s): Dr. Sharon McGee

ClinicalTrials.gov: Not applicable
REaCT-Hot Flashes is a study investigating treatment-related, vasomotor symptoms, in patients with early-stage breast cancer. These symptoms include hot flashes, and sweats, and can occur due to the impacts of chemotherapy, and/or endocrine therapy, on estrogen levels in the body. These symptoms can negatively impact patient quality of life and impair treatment compliance. The goal of this study is to increase our understanding of vasomotor symptoms to help design randomized clinical trials to improve their management.

Sites: London Health Sciences Centre The Ottawa Hospital

Tags: Early stage Breast Cancer Survey

Publications: none to date

REaCT-ZOL

De-escalation of bone drugs (zoledronate infusion every 6 months for 3 years vs 1 zoledronate infusion) for patients with early stage breast cancer.

Principal Investigator(s): Dr. Mark Clemons

ClinicalTrials.gov: NCT03664687
Patients with breast cancer are treated with an intravenous medication called zoledronate which helps keeps the bone strong, reduces the risk of fractures and has a small benefit in preventing breast cancer cells from going to the bone. This medication is associated with side effects such as feelings similar to a flu, bone pains and may rarely effect the kidneys and healing of the jaw bone. Previous clinical trials have shown that 7 doses of this medication is as effective as 19. We also know that these medications stay in the body/bone for a number of years even with a single dose. Based on this, we designed a clinical trial to assess whether 1 dose of this medication maybe as effective as 7 doses in which 211 patients have participated. We are currently following these patients.

Sites: Cancer Centre of Southeastern Ontario (Kingston, Juravinski Cancer Centre (Hamilton)) Southlake Regional Health Centre (Newmarket) The Ottawa Hospital William Osler Health Centre (Brampton)

Tags: Early stage Breast Cancer

Publications: None to date

REaCT-EF

Frequency of cardiac monitoring (echocardiogram or MUGA scan every 4 months vs. every 3 months) for patients with early stage breast cancer.

Principal Investigator(s): Dr. John Hilton

ClinicalTrials.gov: NCT02696707
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in patients with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of patient outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e. damage to the heart) in a small number of patients. During a patient’s trastuzumab treatment, some oncologists order cardiac scans every 3 months while others order every 4 months. At this time, it is not known which standard monitoring schedule is optimal. This study has met accrual and follow-up is ongoing.

Sites: The Ottawa Hospital Thunder Bay Regional Health Sciences Centre

Tags: Early stage Breast Cancer

Publications: none to date

REaCT-BTA

Frequency of treatment of bone targeted agents (every 4 weeks vs every 12 weeks) for patients with metastatic breast cancer or castration-resistant prostate cancer

Principal Investigator(s): Dr. Mark Clemons

ClinicalTrials.gov: NCT02721433
Defining the optimal dosing interval of bone-targeted agents (BTA) for patients with bone metastases is an important question. This trial is comparing 4- versus 12-weekly therapy with any commonly used bone-targeted agent in patients with either metastatic breast or prostate cancer. This study has completed accrual and Year 2 follow up in ongoing.

Sites: Cancer Centre of Southeastern Ontario (Kingston) Cross Cancer Institute (Edmonton) London Health Sciences Centre The Ottawa Hospital Thunder Bay Regional Health Sciences Centre

Tags: Castration-resistant prostate cancer Metastatic breast cancer

Publications:

Systematic Review:

  • Should de-escalation of bone-targeting agents be standard of care for patients with bone metastases from breast cancer? A systematic review and meta-analysis. Ibrahim et al, 2015. PMID: 26122727
  • De-escalation of bone-modifying agents in patients with bone metastases from breast cancer: a systematic review and meta-analysis. Awan et al, 2019. PMID: 31079283

Patient and Physician Surveys:

  • Bone-targeted agent use for bone metastases from breast cancer and prostate cancer: A patient survey. Hutton et al, 2013. PMID: 26909279
  • De-escalated administration of bone-targeted agents in patients with breast and prostate cancer-A survey of Canadian oncologists. Hutton et al, 2013. PMID: 26909274

Commentary and Meeting Abstracts:

  • Dosing Strategies of Bone-Targeting Agents. Hutton et al, 2015. PMID: 26524744
  • The ZOOM trial: more boon than doom? Hutton et al, 2013. PMID: 23993380
  • A randomised trial of 4- versus 12-weekly administration of bone-targeted agents in patients with bone metastases from breast or castration-resistant prostate cancer. Clemons et al, 2019. ASCO 2019 Abstract 11501

Clinical Trial results:

  • A randomised trial of 4- versus 12-weekly administration of bone-targeted agents in patients with bone metastases from breast or castration-resistant prostate cancer. Clemons et al, 2020. PMID: 33023785
REaCT-G and G2

Duration of G-CSF treatment (5 days vs 7/10 days) during chemotherapy

Principal Investigator(s): Dr. Mark Clemons

ClinicalTrials.gov: NCT02428114 NCT02816164
In patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. Improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, the most notable being neutropenia. Neutropenia is the presence of abnormally few white blood cells, leading to increase susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. Febrile neutropenia (FN) can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. Patients can receive medication to reduce the risk of FN such as Neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. Since there is genuine uncertainty among healthcare professionals as to which administration schedule of Neupogen is the best for patients, this randomized trial compared 5, 7 or 10 days of Neupogen.

Sites: Cancer Centre of Southeastern Ontario (Kingston) London Health Sciences Centre Northeast Cancer Centre (Sudbury) Southlake Regional Health Centre (Newmarket) The Ottawa Hospital Thunder Bay Regional Health Sciences Centre

Tags: Early stage Breast Cancer

Publications:

Systematic Review:

  • Primary Febrile Neutropenia Prophylaxis for Patients Who Receive FEC-D Chemotherapy for Breast Cancer: A Systematic Review. Fernandes et al, 2018.  PMID: 30241156

Patient and Physician Surveys:

  • Filgrastim use in patients receiving chemotherapy for early-stage breast cancer-a survey of physicians and patients. Hilton et al, 2018. PMID: 29411131

Clinical Trial results:

  • A multi-center pragmatic, randomized, feasibility trial comparing standard of care schedules of filgrastim administration for primary febrile neutropenia prophylaxis in early-stage breast cancer. Ibrahim et al, 2017. PMID: 29214415
  • A multi-centre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer.  Clemons et al, 2020. PMID: 32325257
REaCT-TC and TC2

Ciprofloxacin vs G-GCSF during chemotherapy

Principal Investigator(s): Dr. Mark Clemons

ClinicalTrials.gov: NCT02173262 NCT02816112
A multi-centre study comparing granulocyte-colony stimulating factors to antibiotics for primary prophylaxis of docetaxel-cyclophosphamide induced febrile neutropenia.

Sites: Cross Cancer Institute (Edmonton) Northeast Cancer Centre (Sudbury) The Ottawa Hospital Tom Baker Cancer Centre (Calgary)

Tags: Early stage Breast Cancer

Publications:

Systematic Review:

  • Optimal primary febrile neutropenia prophylaxis for patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer: a systematic review. Fernandes et al, 2017. PMID: 27783280

Clinical Trial results:

  • Manuscript under review
REaCT-TNBC

Optimal chemotherapy for triple negative breast cancer

Principal Investigator(s): Dr. John Hilton

ClinicalTrials.gov: NCT02688803 
Triple-negative breast cancer (TNBC) is associated with a poorer prognosis than most other types of breast cancer. Despite chemotherapy being the only effective treatment in the curative setting, no one regimen has been identified as being optimal. This study evaluated the feasibility of comparing outcomes for the three most commonly used chemotherapy regimens (Dose dense AC-P vs. FEC-D vs. AC-weekly P) for this disease in an open-label, randomized study. Feasibility was not met in this study and it was closed.

Sites: The Ottawa Hospital

Tags: Early stage Breast Cancer

Publications:

Clinical Trial results:

  • Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients. Jacobs et al, 2017.  PMID: 28127659
REaCT-VA HER2 negative

Peripheral vein access vs. insertion of a PICC central line for breast cancer patients receiving adjuvant HER2 negative chemotherapy

Principal Investigator(s): Dr. Mark Clemons

ClinicalTrials.gov: NCT02688998
It is clear that several factors affect the likelihood a patient will receive a central line for chemotherapy, including: the different durations of commonly used chemotherapy regimens; whether or not the regimen includes an anthracycline; access to services for insertion of devices; patient preference; the ability of the Registered Nurse to locate and cannulate veins for peripheral access and physician practice.  Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. This study is complete.

Sites: Cancer Centre of Southeastern Ontario (Kingston) The Ottawa Hospital

Tags: Early stage Breast Cancer

Publications:

Systematic Review:

  • Optimal vascular access strategies for patients receiving chemotherapy for early stage breast cancer: a systematic review. Robinson et al, 2018.  PMID: 29974358

Surveys:

  • Optimising vascular access for patients receiving intravenous systemic therapy for early stage breast cancer – A survey of oncology nurses and physicians. Levasseur et al, 2018. PMID: 30111975
  • Perceptions around vascular access for intravenous systemic therapy and risk factors for lymphedema in early stage breast cancer – A patient survey. Levasseur et al, 2018. PMID: 30111976

Clinical Trial results:

  • A multicentre, randomized pilot trial comparing vascular access strategies for early stage breast cancer patients receiving non-trastuzumab containing chemotherapy. Robinson et al, 2019.  PMID: 31392518
REaCT-VA HER2 positive

Central line access (PICC vs PORT) for breast cancer patients receiving adjuvant chemotherapy plus Herceptin

Principal Investigator(s): Dr. Mark Clemons

ClinicalTrials.gov: NCT02632435
Intravenous trastuzumab is a common treatment regime for patients with early stage breast cancer. Adjuvant breast cancer chemotherapy require repeated visits to the chemotherapy unit and blood testing, along with trastuzumab treatment for 1 year. Thus vascular access devices are required to assist in efficient and effective treatment delivery and to improve patient experience. The best practice of type of vascular access is currently unknown (PICC vs. PORT).  This study is complete.

Sites: The Ottawa Hospital

Tags: Early stage Breast Cancer

Publications:

Systematic Review:

  • A randomized trial comparing vascular strategies for patients receiving chemotherapy trastuzumab for early-stage breast cancer. Clemons et al, 2020.  PMID: 32002617
REaCT-DEX

Missed dexamethasone premedication during docetaxel chemotherapy

Principal Investigator(s): Dr. Tina Hsu

ClinicalTrials.gov: NCT02815319 
Docetaxel chemotherapy is commonly used in breast cancer patients, however side effects are common, including acute hypersensitivity reactions, capillary leak syndrome and skin toxicities. Steroid premedication is given with docetaxel chemotherapy to prevent many of these side effects. Currently there is no standard of care procedure if a patient forgets to take any or all of their steroid premedication. This can lead to significant treatment delays while the patient waits for the CTU nurse to contact the treating physician, obtain a replacement strategy and then fill the order with pharmacy.  This study compares a set replacement regimen with physician’s choice regimen in the hopes of reducing the wait time for chemotherapy. This study is complete

Sites: The Ottawa Hospital

Tags: None

Publications:

Survey:

  • Optimisation of steroid prophylaxis schedules in breast cancer patients receiving docetaxel chemotherapy-a survey of health care providers and patients. Jacobs et al, 2015. PMID: 25933700

Clinical Trial results:

  • A randomised clinical trial comparing physician-directed or fixed-dose steroid replacement strategies for incomplete dexamethasone dosing prior to docetaxel chemotherapy. Hsu et al, 2020. PMID: 33057999
REaCT-ADM

Comparison of acellular dermal matrices in breast reconstruction surgery

Principal Investigator(s): Dr. Angel Arnaout

ClinicalTrials.gov: NCT03064893
Acellular dermal matrix (ADM) are increasingly used in breast reconstruction after mastectomy. Various ADMs are available on the market with varying costs despite similar quality. The two most commonly used ADM products in North America are Alloderm and Dermacell, each of which have been shown to be safe and effective and are equally available in Canadian hospitals. The aim of this study is to evaluate the postsurgical complications of Alloderm vs Dermacell use in immediate breast reconstruction.  This study has been completed.

Sites: The Ottawa Hospital

Tags: None

Publications:

  • Manuscript under review
REaCT-Mg

Magnesium replacement strategies for patients receiving palliative-intent treatment with Cisplatin, Carboplatin, Panitumumab or Cetuximab 

Principal Investigator(s): Dr. Michael Vickers

ClinicalTrials.gov: NCT02690012
Hypomagnesemia is a common consequence of many anti-cancer therapies. However optimal replacement strategies are unknown. The trial assessed the feasibility of comparing the benefits of treating hypomagnesemia to magnesium oxide or magnesium citrate in patients receiving palliative treatment with cisplatin, carboplatin, Panitumumab or Cetuximab. This study has been completed.

Sites: The Ottawa Hospital

Tags: Palliative chemotherapy

Publications:

  • Manuscript under review