Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body
This phase III trial studies how well the addition of radiotherapy to the usual treatment
(chemotherapy) works compared to the usual treatment alone in treating patients with
esophageal and gastric cancer that has spread to a limited number of other places in the body
(oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to
kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin,
5-fluorouracil, oxaliplatin, 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. Adding radiotherapy to the usual chemotherapy may work better compared to the
usual chemotherapy alone in treating patients with esophageal and gastric cancer.
Description
PRIMARY OBJECTIVE:
I. To establish superiority of consolidative radiation therapy over continuation of systemic
therapy alone in patients with oligometastatic esophageal and gastric adenocarcinoma (EGA)
that does not progress on first-line therapy.
OUTLINE
STEP 1 (INDUCTION PHASE): Patients are assigned to 1 of 2 arms.
ARM A: Patients receive oxaliplatin intravenously (IV) over 1.5 hours, leucovorin IV over 1.5
hours, and 5-fluorouracil IV over 46-48 hours on days 1 and 15. Treatment repeats every 28
days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive oxaliplatin IV over 2 hours on day 1 and capecitabine orally (PO)
twice daily (BID) on days 1-14. Treatment repeats every 21 days for up to 6 cycles in the
absence of disease progression or unacceptable toxicity.
STEP 2: Patients are randomized to 1 of 4 arms.
ARM C: One week post induction of patients in ARM A, patients undergo radiation therapy for
up to 15 days. Within 2-4 weeks post radiation therapy, patients receive oxaliplatin,
leucovorin, and 5-fluorouracil as in Arm A for 2 years in the absence of disease progression
or unacceptable toxicity.
ARM D: Post induction of patients in ARM A, patients continue oxaliplatin, leucovorin, and
5-fluorouracil as in Arm A for 2 years in the absence of disease progression or unacceptable
toxicity.
ARM E: One week post induction of patients in ARM B, patients undergo radiation therapy for
up to 15 days. Within 2-4 weeks post radiation therapy, patients receive oxaliplatin and
capecitabine as in Arm B for 2 years in the absence of disease progression or unacceptable
toxicity.
ARM F: Post induction of patients in ARM B, patients continue oxaliplatin and capecitabine as
in Arm B for 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 5 years
from study entry. Patients experiencing disease progression are followed up every 3 months in
years 1-2, and then every 6 months for up to 5 years from study entry.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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