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.
• 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