Clinical trial for Esophageal Cancer
Official title Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophagogastric Cancer: (TORO Protocol)
ClinicalTrials.gov ID: NCT06668454
What this study is testing
- What it's testing
- The study wants to see if adding surgery, and sometimes targeted radiation, after chemoimmunotherapy helps patients with oligometastatic esophageal or gastric cancer live longer.
- Who it's for
- Adults who have esophageal or gastric cancer that has spread only to a few sites (oligometastatic disease).
- What's involved
- Participants will receive a combination of chemotherapy and immunotherapy before surgery, then have the tumor removed and may also get focused radiation (SBRT).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Histologically-proven cT1-4aN0-3M1 adenocarcinoma or squamous cell carcinoma of the esophagus, or EGJ according to the 8th edition of the Union for...
- Oligometastatic disease, which is defined as a maximum of five metastatic lesions, that is treatable by surgical resection or radiation.
- 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...
- Adequate blood work parameters for systemic therapy as per treating medical oncologist in terms of ANC, platelet count and hemoglobin.
You likely can't join if
- Patients with overt peritoneal or pleural dissemination, as detected on PET-CT or regular CT-scan.
- 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...
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for the study
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or...
- Patients with active pregnancy, or lactation.
See the full eligibility criteria
- 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...
- Oligometastatic disease, which is defined as a maximum of five metastatic lesions, that is treatable by surgical resection or radiation.
- 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
- Patients with overt peritoneal or pleural dissemination, as detected on PET-CT or regular CT-scan.
- 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.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for the study
- 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...
- Patients with active pregnancy, or lactation.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.