Esophageal CancerTORONCT06668454
Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophagogastric Cancer: (TORO Protocol)
A study testing Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer in people with Esophageal Cancer and Gastric Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Esophageal cancer and cancers of the gastroesophageal junction (GEJ) are among the most common malignancies worldwide. The outcome for these patients remains very poor. Patients with limited spread of their cancer (oligometastatic disease) have a better prognosis than those with widespread disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer, Oligometastatic Disease
- What is being tested?
- Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 9 May 2025to 9 May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-proven cT1-4aN0-3M1 adenocarcinoma or squamous cell carcinoma of the esophagus, or EGJ according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification for Esophageal Cancer;
- Oligometastatic disease, which is defined as a maximum of five metastatic lesions, that is treatable by surgical resection or radiation. These five lesions can be present in a maximum of two organs (eg, liver, lung or adrenal gland). Lymph nodes are not counted as an organ. If metastatic retroperitoneal or supraclavicular lymph nodes are present, this lymph node site counts as one metastatic lesion, and together with the possible metastases in organs cannot exceed the number of five lesions.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Adequate cardiac and respiratory function by standard electrocardiogram and additional diagnostics in case of cardiopulmonary complaints or comorbidity (i.e. lung function test, or echocardiography)
- Adequate blood work parameters for systemic therapy as per treating medical oncologist in terms of ANC, platelet count and hemoglobin.
- Adequate renal function (glomerular filtration rate >50 mL/min or serum creatinine ≤1.5x upper level of normal (ULN)) and adequate liver function (total bilirubin < 2.5x ULN and alanine transaminase (ALT) < 3x ULN);
- A negative serum pregnancy test in women of child-bearing potential during screening period.
- Age >18 and <80 years old
Who cannot join
- Patients with overt peritoneal or pleural dissemination, as detected on PET-CT or regular CT-scan. In patients in whom a diagnostic laparoscopy is indicated (to assess gastric involvement and the possibility to perform gastric tube reconstruction or to exclude peritoneal disease), tumor-positive cytology peritoneal fluid is also an exclusion criteria. Of note, positive microscopic peritoneal cytology which converts to negative after treatment is not an exclusion criteria (i.e. peritoneal or pleural fluid cytology must be negative at the time of enrollment, with no gross disease identified initially).
- Multiple bone or brain metastases - up to one solitary bone met and/one solitary brain met is allowable as a metastatic site, if curative ablative radiotherapy can be given at the discretion of the treating physicians. Patients with multiple brain metastases or multiple bone metastases will be excluded.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for the study; particularly any condition that would make the patient unfit for surgery, radiation, chemotherapy or a combination thereof.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a form of systemic treatment and is allowed. Use of non-systemic steroids is permitted.
- Patients with active pregnancy, or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
Frances Allison, 437-233-4303, Frances.Allison@uhn.ca
About this study
Official title: Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophageal and Gastric Cancer: A Phase II Clinical Trial (TORO Protocol)
Esophageal cancer and cancers of the gastroesophageal junction (GEJ) are among the most common malignancies worldwide. The outcome for these patients remains very poor. Patients with limited spread of their cancer (oligometastatic disease) have a better prognosis than those with widespread disease. Recent advances in treatment therapies, including use of pre-operative immunotherapy, surgery and/or targeted radiation (SBRT) may help to prolong lifespan in patients with oligometastatic disease. Patients will undergo treatment for their oligometastatic esophageal or gastric cancer with pre-operative chemoimmunotherapy followed by surgery and possibly SBRT to evaluate the value of adding surgery and possibly SBRT to their treatment.
Read the detailed description
Esophageal cancer and cancers of the gastroesophageal junction (GEJ) are among the most common malignancies worldwide, and the prognosis for patients with metastatic disease remain very poor. However, recent advances in systemic treatment modalities have shown promise for patients with oligometastatic disease, in particular with the incorporation of immunotherapy an targeted agents into systemic treatment regimens. The definition of oligometastatic disease varies across studies and primary sites, but it is generally agreed that patients with oligometastatic disease have a more favorable prognosis than those with widespread metastases. For patients with oligometastatic disease, which is variably defined as the presence of a limited number of metastases, the role of local treatment remains controversial. Chemoimmunotherapy followed by surgery has emerged as a potential treatment option for oligometastatic esophageal and gastric cancer, but further research is needed to evaluate its efficacy and safety and to provide prospective survival and recurrence information.
Several studies have investigated the use of surgery for oligometastatic esophageal cancer after chemo-immunotherapy. A retrospective study of 47 patients with oligometastatic esophageal cancer who underwent immunotherapy and surgery found that the median overall survival was 22 months, and the 2-year overall survival rate was 47.8%. A phase II study of chemoimmunotherapy followed by surgery for patients with oligometastatic esophageal cancer found that the 2-year progression-free survival rate was 60%, and the median overall survival had not been reached at the time of analysis. These studies suggest that surgery after immunotherapy may be associated with better survival outcomes for patients with oligometastatic esophageal cancer, but further research is needed to confirm these findings. SBRT has been evaluated previously in oligometastatic disease in a number of different settings, including in our own institution in studies that included esophageal cancer patients, although in very small numbers. These studies were encouraging but a more thorough evaluation in combination with surgical resection has not been completed.
- Conditions
- Esophageal Cancer, Gastric Cancer, Oligometastatic Disease
- Being tested
- Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancerProcedure or surgery
Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer
| Study group | Role | What they receive |
|---|---|---|
| Surgical Arm | Other | Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer Receives: Procedure: Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival outcomes for patients undergoing systemic treatment, primarily with chemoimmunotherapy, followed by surgery in patients with oligometastatic esophageal and GEJ cancer
Measured: 5 years
Secondary outcomes (4)
Surgical safety
Review of surgical safety, defined by surgical complications
Measured: Within first 30 days after surgery
Mortality
Review of surgical safety, defined by mortality within the first 30 days
Measured: Within first 30 days after surgery
Progression free survival
Review of distant and loco-regional recurrence
Measured: 2 years and 5 years
Quality of Life questionnaires
Use of FACT E questionnaires at different timepoints to assess patient reported outcomes
Measured: Pre-treatment, post-chemoimmunotherapy/pre-op, post op visit @ 30 days, 6 months, 1 year, 18 months and 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start9 May 2025
- Primary completion9 May 2035 (estimated)
- Study completion9 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Elliot Wakeam, Principal investigator, Toronto General Hospital-UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668454
- Sponsor's protocol ID
- CTO Project 4717
- Acronym
- TORO
- Status last verified
- May 2025
- First submitted
- 25 Oct 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophageal and Gastric Cancer: A Phase II Clinical Trial (TORO Protocol)
- ClinicalTrials.gov ID
- NCT06668454
- Acronym / sponsor ID
- TORO / CTO Project 4717
- Conditions
- Esophageal Cancer, Gastric Cancer, Oligometastatic Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 9 May 2025 (actual)
- Primary completion
- 9 May 2035 (estimated)
- Study completion
- 9 May 2035 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Esophageal cancer and cancers of the gastroesophageal junction (GEJ) are among the most common malignancies worldwide. The outcome for these patients remains very poor. Patients with limited spread of their cancer (oligometastatic disease) have a better prognosis than those with widespread disease. Recent advances in treatment therapies, including use of pre-operative immunotherapy, surgery and/or targeted radiation (SBRT) may help to prolong lifespan in patients with oligometastatic disease. Patients will undergo treatment for their oligometastatic esophageal or gastric cancer with pre-operative chemoimmunotherapy followed by surgery and possibly SBRT to evaluate the value of adding surgery and possibly SBRT to their treatment.
Detailed description
Esophageal cancer and cancers of the gastroesophageal junction (GEJ) are among the most common malignancies worldwide, and the prognosis for patients with metastatic disease remain very poor. However, recent advances in systemic treatment modalities have shown promise for patients with oligometastatic disease, in particular with the incorporation of immunotherapy an targeted agents into systemic treatment regimens. The definition of oligometastatic disease varies across studies and primary sites, but it is generally agreed that patients with oligometastatic disease have a more favorable prognosis than those with widespread metastases. For patients with oligometastatic disease, which is variably defined as the presence of a limited number of metastases, the role of local treatment remains controversial. Chemoimmunotherapy followed by surgery has emerged as a potential treatment option for oligometastatic esophageal and gastric cancer, but further research is needed to evaluate its efficacy and safety and to provide prospective survival and recurrence information.
Several studies have investigated the use of surgery for oligometastatic esophageal cancer after chemo-immunotherapy. A retrospective study of 47 patients with oligometastatic esophageal cancer who underwent immunotherapy and surgery found that the median overall survival was 22 months, and the 2-year overall survival rate was 47.8%. A phase II study of chemoimmunotherapy followed by surgery for patients with oligometastatic esophageal cancer found that the 2-year progression-free survival rate was 60%, and the median overall survival had not been reached at the time of analysis. These studies suggest that surgery after immunotherapy may be associated with better survival outcomes for patients with oligometastatic esophageal cancer, but further research is needed to confirm these findings. SBRT has been evaluated previously in oligometastatic disease in a number of different settings, including in our own institution in studies that included esophageal cancer patients, although in very small numbers. These studies were encouraging but a more thorough evaluation in combination with surgical resection has not been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Arm | Other | Procedure: Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancerSurgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically-proven cT1-4aN0-3M1 adenocarcinoma or squamous cell carcinoma of the esophagus, or EGJ according to the 8th edition of the Union for International Cancer Control (UICC) TNM classification for Esophageal Cancer;
- Oligometastatic disease, which is defined as a maximum of five metastatic lesions, that is treatable by surgical resection or radiation. These five lesions can be present in a maximum of two organs (eg, liver, lung or adrenal gland). Lymph nodes are not counted as an organ. If metastatic retroperitoneal or supraclavicular lymph nodes are present, this lymph node site counts as one metastatic lesion, and together with the possible metastases in organs cannot exceed the number of five lesions.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Adequate cardiac and respiratory function by standard electrocardiogram and additional diagnostics in case of cardiopulmonary complaints or comorbidity (i.e. lung function test, or echocardiography)
- Adequate blood work parameters for systemic therapy as per treating medical oncologist in terms of ANC, platelet count and hemoglobin.
Key exclusion criteria (5 listed)
- Patients with overt peritoneal or pleural dissemination, as detected on PET-CT or regular CT-scan. In patients in whom a diagnostic laparoscopy is indicated (to assess gastric involvement and the possibility to perform gastric tube reconstruction or to exclude peritoneal disease), tumor-positive cytology peritoneal fluid is also an exclusion criteria. Of note, positive microscopic peritoneal cytology which converts to negative after treatment is not an exclusion criteria (i.e. peritoneal or pleural fluid cytology must be negative at the time of enrollment, with no gross disease identified initially).
- Multiple bone or brain metastases - up to one solitary bone met and/one solitary brain met is allowable as a metastatic site, if curative ablative radiotherapy can be given at the discretion of the treating physicians. Patients with multiple brain metastases or multiple bone metastases will be excluded.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for the study; particularly any condition that would make the patient unfit for surgery, radiation, chemotherapy or a combination thereof.
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered a form of systemic treatment and is allowed. Use of non-systemic steroids is permitted.
- Patients with active pregnancy, or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancerSurgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer | Procedure or surgery | Surgical Arm |
Primary outcome
Overall survival
Time frame: 5 years
Overall survival outcomes for patients undergoing systemic treatment, primarily with chemoimmunotherapy, followed by surgery in patients with oligometastatic esophageal and GEJ cancer
4 secondary outcomes
Surgical safety
Time frame: Within first 30 days after surgery
Mortality
Time frame: Within first 30 days after surgery
Progression free survival
Time frame: 2 years and 5 years
Quality of Life questionnaires
Time frame: Pre-treatment, post-chemoimmunotherapy/pre-op, post op visit @ 30 days, 6 months, 1 year, 18 months and 2 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Elliot Wakeam principal investigator
Toronto General Hospital-UHN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer in people with Esophageal Cancer and Gastric Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frances Allison (437-233-4303, Frances.Allison@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.