Actively Recruiting
Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophageal and Gastric Cancer: A Phase II Clinical Trial (TORO Protocol)
Led by University Health Network, Toronto · Updated on 2025-05-16
72
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Esophageal cancer and cancers of the gastroesophageal junction (GEJ) are common and serious worldwide, especially when they have spread. Patients with a limited number of metastases, called oligometastatic disease, often have a better outlook than those with widespread cancer. This trial aims to evaluate the effects of combining pre-operative chemoimmunotherapy with surgery and possibly targeted radiation (SBRT) in treating oligometastatic esophageal and gastric cancers to better understand survival and recurrence outcomes. Participants will receive pre-operative chemoimmunotherapy followed by surgery to remove cancerous tissue. In some cases, targeted radiation (SBRT) may also be given to treat remaining metastases. This approach is being studied to see if adding surgery and radiation to chemoimmunotherapy improves outcomes. The study is a phase II clinical trial and will assess the safety and effectiveness of this combined treatment approach. Throughout the study, participants will have regular assessments including survival tracking for up to five years. Safety will be monitored closely, especially during the first 30 days after surgery, along with progression-free survival measured at two and five years. Quality of life questionnaires will be completed at several time points before and after treatment to understand the impact on daily living. This comprehensive monitoring aims to provide a clearer picture of how this treatment affects both cancer control and patient well-being.
CONDITIONS
Brief Title
Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophagogastric Cancer: (TORO Protocol)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged greater than 18 and less than 80 years old
- Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
- Oligometastatic disease with up to five metastatic lesions treatable by surgery or radiation involving no more than two organs
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate heart and lung function as determined by standard tests
- Adequate blood counts and organ functions suitable for systemic therapy
- Negative pregnancy test for women of child-bearing potential
You will not qualify if you...
- Presence of widespread peritoneal or pleural cancer spread detected by scans
- Positive tumor cells in peritoneal fluid at enrollment
- Multiple bone or brain metastases beyond one solitary bone or brain lesion
- Any condition making the patient unfit for surgery, chemotherapy, or radiation
- Active autoimmune disease requiring systemic treatment in the past two years except certain exceptions
- Current pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of preoperative chemoimmunotherapy until surgery (variable based on treatment plan)
Participants receive preoperative chemoimmunotherapy followed by surgical resection for oligometastatic esophagogastric cancer.
Regular visits for chemoimmunotherapy and 1 surgery visit
Duration - Up to 5 years
Participants are monitored for safety, survival, and quality of life after surgery.
Visits at 30 days, 6 months, 1 year, 18 months, 2 years, and 5 years post-surgery
Trial Site Locations
Total: 1 location
1
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
F
Frances Allison
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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