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3CTN Supporting Trial Development in the Adolescent and Young Adult (AYA) Population

Adolescents and Young Adults (AYA) diagnosed with cancer have a unique set of challenges throughout their cancer journey and historically there have been limited formal clinical trials available to this population. To help support research in this important yet underserved segment of the Canadian cancer population, 3CTN is facilitating the development of a new clinical trial for the AYA population. The process began in the spring of 2015 with the release of a request for applications, which asked AYA researchers to submit clinical trial proposals.

Over the past few months, through a formal review and selection process, one project proposal for a trial in Acute Lymphoblastic Leukemia (ALL) was ultimately selected. On November 30 2015, 3CTN and our collaborators* held a workshop in Montreal, Quebec focused on developing this proposed pan-Canadian clinical trial. The workshop brought together principal investigators and site research staff from many Canadian pediatric and adult cancer centres with the common goal of launching a trial to address current knowledge gaps in AYA ALL therapy. Topics covered at the workshop included prioritizing the clinical needs of AYA ALL patients, identification of potential new agents and the status of the relevant diagnostic tests that will be required for a trial. A smaller working group will now focus on designing a draft protocol for a study to open within the next year. Clinical trials targeted to AYA with ALL will ultimately improve the standard of care and health outcomes for this population.

After the workshop, 3CTN provided a satisfaction survey and invited participants to provide feedback on the workshop. Nearly 70 per cent of attendees responded to the survey and indicated that overall, they were pleased with the workshop and that it met its stated goals and objectives.

The final goal of this AYA ALL trial development process will be a clinical trial in which Network centres can participate via the 3CTN Portfolio. Collectively our Network’s involvement may help decrease the knowledge gap in therapy for AYA Canadians diagnosed with ALL.

*The AYA Trial development workshop was sponsored in part by 3CTN and Jazz Pharmaceuticals (unrestricted educational grant). In addition, this workshop would not have been possible without the assistance of 3CTN, C17 and SickKids staff, in particular Donna Berry, Program Manager, Garron Family Cancer Centre.

AYA workshop attendees, November 10, 2015, Montreal, Quebec

Recruitment

Figure 1. Recruitment to Year 2 Network target by local regional node (Network Target = Baseline + 25 per cent). Progress has been calculated based on Year 2 recruitment reports from sites and year to date target. Note: Any regional node exceeding the green bar are on track to meet Year 2 annual Network recruitment target.

Patient and Public Involvement

Enhancements to the 3CTN PPI Website!

3CTN launched the 3CTN Guide to Patient and Public Involvement as a part of the 2015 Annual Stakeholder meeting. While this Guide represents one major pillar of the 3CTN PPI program, it is best viewed as a ‘jumping off point’ when Network site staff and Lay Representatives want to learn about PPI within the 3CTN framework. 3CTN tools and information are found on the “Patient/Public” tab on the main 3CTN webpage.

The PPI website enhancements augment the PPI Guide by providing more education and tools for 3CTN stakeholders interested in 3CTN PPI activities. The main changes to the website are described below:

“Live” PPI Toolkits:

The addition of two PPI Toolkits will be very helpful for 3CTN site staff and Lay Representatives. On the main PPI page there are separate toolkits for “Network Sites” and “Lay Representatives”, with user specific information and tools. In the Lay Representative toolkit, one feature new 3CTN Lay Representatives may find useful is the ‘Helpful Links’ section, which lists clinical trial training and information websites. More 3CTN PPI tools will be added to their respective toolkit in the coming months.

PPI News

The PPI News page is yet another development on the 3CTN PPI website. This page will highlight exciting activities and advancements within the PPI program. All 3CTN stakeholders are encouraged to submit stories ideas or other PPI-related announcements to the 3CTN Coordinating Centre to be posted on this page.

The 3CTN Coordinating Centre and the Lay Representative Advisory Council are excited about what the PPI website enhancements can offer to Network sites and Lay Representatives to support PPI activities across the Network. If you have feedback or suggestions for website improvements, feel free to contact us info@3ctn.ca

3CTN at the 2015 Canadian Cancer Research Conference

Dr. Janet Dancey, 3CTN’s Scientific Director, recently provided an overview and update on 3CTN’s year one activities at the Canadian Cancer Research Conference in Montreal. The talk, entitled “3CTN: Increasing Capacity to Conduct 21st Century Academic Cancer Trials”, focused on describing 3CTN’s structure and promoting general awareness of 3CTN as a valuable initiative in the Canadian academic trial environment. Dr. Dancey also encouraged site staff to get involved in 3CTN committees and initiatives. Additionally some content focused on the Portfolio as a tool for the academic community to find out about potential clinical trials they may be interested in opening locally.

3CTN was also highlighted at the poster session. The poster educated conference attendees about 3CTN’s structure and function, and progress that will be vital to 3CTN achieving its overall goals and objectives.

Feature Trials:

PCS VI

Comparative Study of Radiotherapy Treatments to Treat High Risk Prostate Cancer Patients
Sponsor:
Jewish General Hospital
NCT#: NCT02303327
Significance: The unique radiobiology characteristic of prostate cancer cells suggests that they respond more favourably to larger radiation fraction size than other malignancies. This allows for dose escalation and hypofractionated radiation delivery. Prostate cancer cells respond even more favourably to the larger high dose rate brachytherapy radiation fraction size. This trial is designed to compare conventional pelvic radiation therapy followed by a HDRB boost to the prostate to the hypofractionated radiation therapy for high risk prostate cancer patients.
Sites open: 7 (CHUM - Hôpital Notre-Dame, Centre de santé Rimouski-Neigette, Hôpital Charles-LeMoyne, CHUQ- L'Hotel-Dieu de Québec, Hôpital Maisonneuve-Rosemont, CHUS-Hôpital Fleurimont and Jewish General Hospital)
Pending sites: 5
Open to additional Canadian sites: Yes
Current status: 27/296 patients have been randomized

TRAD, OZM-056

Treatment-free Remission Accomplished With Dasatinib in Patients With CML
Sponsor:
University Health Network
NCT#: NCT02268370
Significance: Operational cure has become the ultimate goal in the current era of treatment discontinuation of TKI therapy for CML. However, unsuccessful in around 50 per cent of patients, it has not known whether patients may have the same chance of operational cure after failing first attempt of TKI discontinuation. If retreatment with dasatinib allows one third of those patients who relapse after imatinib discontinuation to stay off therapy, this would be of significant clinical benefit. If the ancillary laboratory studies provide insight into the mechanism whereby this outcome occurs, this would be of substantial scientific interest.
Sites open: 9 (Princess Margaret Cancer Centre, Tom Baker Cancer Centre, Vancouver General Hospital, Queen Elizabeth II – Health Sciences Centre, Juravinski Cancer Centre, London Health Sciences Centre, Ottawa General Hospital, Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus, Hopital Maisonneuve-Rosemont)
Pending sites: 3 (CancerCare Manitoba, McGill University Health Centre- Cedar Cancer Centre, University of Alberta Hospital)
Open to additional Canadian sites: No
Current status: 32/135 patients have been enrolled

What’s new with EDGE?

Many sites expressed interest in using EDGE. Recent progress updates are as follows:

  • The BC Cancer Agency hired EDGE Super User in late November;
  • Monthly Super User teleconferences scheduled starting on December 14, 2015;
  • Target go live date of January 5, 2016 for the first pilot site, Ottawa Hospital Cancer Centre for selected disease site groups;
  • Weekly teleconferences held with BCCA for implementation planning and configuration, with an aim to go live in early 2016.
  • For more information on EDGE, contact Rebecca Xu or visit the 3CTN website.

What's New?

Network Roll Out

  • A 3CTN modified structure in Quebec has been confirmed. Agreement with Q-CROC NRCC is ongoing and will be finalized in December;
  • Updated PPI section is now available at http://3ctn.ca/page/patient-public
  • Edge Super User in BC hired

Network Performance

  • Network 18 month e-review package sent to Scientific Advisory Board

Network Research

  • Review meeting held for Janssen Prostate Cancer research projects. Award recipient to be notified by December 2015

Key Dates

December 9, 2015: SAB 18 month review

December 17, 2015: Steering Committee winter meeting

February 4-5, 2016: N2 Annual Meeting. For more information and to register: https://events.oicr.on.ca/n2-2016

February 11, 2016: Portfolio Committee meeting

March 4, 2016 SAB 18 month face-to-face review

Announcements from our Partners

  • N2 has launched a website created for the public to learn about clinical research and trials - www.itstartswithme.ca;
  • Canadian Breast Cancer Foundation newly launched webpage on clinical trials - www.cbcf.org/BreastCancerTrials.
  • Contact Us

    For inquiries please contact: info@3ctn.ca or call 1-866-678-6427

    Canadian Cancer Clinical Trials Network, MaRS Centre, 661 University Ave,
    Suite 510 Toronto, Ontario Canada M5G 0A3

    www.3ctn.ca

     






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