NCT04871412 The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial - Stage III
| NCT ID | NCT04871412 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-04-04 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 20 participants in total. It began in 2022-04-04 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. Too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings. The Thoracic POISE project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery.
Eligibility Criteria
Inclusion criteria • Adults eligible for complete resection of lung, gastric or esophageal cancer Exclusion criteria * Small cell, carcinoid, or gastrointestinal stromal (GIST) tumours * Any wedge resections of lung cancer * History of cancer with active treatment in the last 3 years (not including superficial bladder cancer or non-melanoma skin cancer) * Patients currently receiving care guided by an ND or who have previously seen an ND in the last 3 months * Pregnant or breastfeeding women\* * Any reason which, in the opinion of the Principal Investigator (or delegate), would prevent the subject from participating in the study * Use of an investigational drug or participation in an investigational study within 30 days prior to starting the study
Contact & Investigator
Andrew Seely, MD, PhD, FRCSC
PRINCIPAL INVESTIGATOR
Ottawa Hospital Research Institute
Frequently Asked Questions
Who can join the NCT04871412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04871412 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 20 participants.
Is NCT04871412 currently recruiting?
Yes, NCT04871412 is actively recruiting participants. Contact the research team at afazekas@toh.ca for enrollment information.
Where is the NCT04871412 trial being conducted?
This trial is being conducted at Ottawa, Canada, Toronto, Canada.
Who is sponsoring the NCT04871412 clinical trial?
NCT04871412 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Andrew Seely, MD, PhD, FRCSC at Ottawa Hospital Research Institute. The trial plans to enroll 20 participants.
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