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

NCT06668454 | Recruiting

• 1 other identifier: CTO Project 4717
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Esophageal Cancer; Gastric Cancer; Oligometastatic Disease

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival outcomes for patients undergoing systemic treatment, primarily with chemoimmunotherapy, followed by surgery in patients with oligometastatic esophageal and GEJ cancer

  5 years

Secondary Outcomes (4)

• Surgical safety

  Within first 30 days after surgery

• Mortality

  Within first 30 days after surgery

• Progression free survival

  2 years and 5 years

• Quality of Life questionnaires

  Pre-treatment, post-chemoimmunotherapy/pre-op, post op visit @ 30 days, 6 months, 1 year, 18 months and 2 and 5 years

Study Arms (1)

Surgical Arm

OTHER

Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer

Procedure: Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer

Interventions

Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer PROCEDURE

Surgical resection followed by preoperative chemoimmunotherapy for oligometastatic esophagogastric cancer

Surgical Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Dr. Elliot Wakeam

  Toronto General Hospital-UHN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frances Allison

CONTACT

437-233-4303; Frances.Allison@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 31, 2024
• Study Start: May 9, 2025
• Primary Completion (Estimated): May 9, 2035
• Study Completion (Estimated): May 9, 2035
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CA (1)