Chemoimmunotherapy Followed by Surgery for Oligometastatic Esophagogastric Cancer: (TORO Protocol)

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Oct 30, 2024

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ClinConnect Summary

The TORO Protocol clinical trial is studying a new treatment approach for patients with oligometastatic esophagogastric cancer, which is a type of cancer that has spread to a limited number of areas in the body. The treatment involves a combination of chemotherapy and immunotherapy before surgery, and possibly using targeted radiation after surgery, to see if these combined methods can improve survival rates for patients. This trial is important because patients with limited spread of their cancer generally have better outcomes, and the researchers want to find out if adding surgery and radiation can make a difference in their treatment.

To participate in this trial, patients need to be between the ages of 18 and 80 and have a specific type of esophageal or gastric cancer that has spread to no more than five areas, which can include organs like the liver or lungs. They also need to be in good overall health, with sufficient heart and lung function. Unfortunately, patients with more advanced disease, such as multiple metastases or active autoimmune conditions, cannot join the study. If eligible, participants can expect to undergo treatment that includes chemotherapy and immunotherapy, followed by surgery and possibly radiation, all while being closely monitored by the research team. This trial is not yet recruiting participants, but it holds promise for improving treatment options for this challenging type of cancer.

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Eligibility criteria

• Inclusion 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 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
• Exclusion Criteria:
• • 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.