This phase II trial studies how well chemotherapy with or without radiation or surgery works in treating participants with esophageal or gastric cancer that has spread to less than 3 places in the body (oligometastatic). Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, irinotecan, docetaxel and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Surgery, such as complete surgical resection, may stop the spread of tumor cells by surgically removing organs or tumors. Giving chemotherapy with radiation or surgery may work better than chemotherapy alone in treating participants with oligometastatic esophageal or gastric cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT03161522.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Quynh-Nhu Nguyen
Phone: 713-563-2300
PRIMARY OBJECTIVES:
I. To evaluate whether esophageal or gastric patients with oligometastatic cancer without disease progression after first line systemic therapy (chemotherapy therapy, targeted molecular therapy, or immunotherapy) will demonstrate improved progression free survival (PFS) with early local therapy (concurrent chemotherapy/radiation and surgery).
SECONDARY OBJECTIVES:
I. Assess overall survival (OS).
II. Assess the relationships between progression-free survival and overall survival between both treatment arms.
III. Report local control, loco-regional control.
IV. Report time to progression of distant metastases.
V. Report toxicity.
OUTLINE:
Patients receive induction chemotherapy for a minimum of 6 cycles and a maximum of 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo imaging scans during induction chemotherapy that may include any of the following: computed tomography (CT), positron emission tomography (PET)/CT, and/or endoscopic ultrasound (EUS). Patients with no radiographic evidence of progression of disease are then randomized to 1 of 2 groups.
GROUP I (MAINTENANCE CHEMOTHERAPY): Patients receive fluorouracil or capecitabine and oxaliplatin, irinotecan, or docetaxel per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Patients may also undergo CT, PET/CT, and/or EUS at discretion of the treating physician.
GROUP II (LOCAL THERAPY): Patients receive chemotherapy at the discretion of the treating physician and undergo radiation therapy (RT) per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Patients may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician. Patients may also undergo CT, PET/CT, and/or EUS at discretion of the treating physician.
After completion of study treatment, participants are followed up at 4-8 weeks, 2-3 months, every 3-6 months for up to 3 years, and then every 6-12 months thereafter.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorQuynh-Nhu Nguyen