Study of radiotherapy added to chemotherapy for certain metastatic GI cancers

Study ID: EA2183

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 3 trial studies how well the addition of radiation therapy  to the usual treatment (chemotherapy) works compared to chemotherapy alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body.

Participants are randomized intro treatment groups and followed for up to five years.

This study seeks to establish superiority of consolidative radiation therapy over continuation of systemic therapy alone in patients with oligometastatic esophageal and gastric adenocarcinoma that does not progress on first-line therapy.

During the induction phase (Step 1), participants are assigned to either Arm A or B, and then during Step 2 are randomized into other groups as noted below:

Arm A: Patients receive oxaliplatin 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.

  • Arm C: One week post induction in Arm A, patients undergo radiotherapy for up to 15 days. Within 2-4 weeks post radiotherapy, patients receive oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years.
  • Arm D: Post induction in Arm A, patients continue oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years.

Arm B: Patients receive oxaliplatin IV over 2 hours on day 1 and capecitabine PO twice daily on days 1-14. Treatment repeats every 21 days for up to 6 cycles

  • Arm E: One week post induction in Arm B, patients undergo radiotherapy for up to 15 days. Within 2-4 weeks post radiotherapy, patients receive oxaliplatin and capecitabine as in Arm B for 2 years. 
  • Arm F: Post induction in Arm B, patients continue oxaliplatin and capecitabine as in Arm B for 2 years.

Note: The choice of treatment, CAPOX or FOLFOX, is selected by the investigator during Step 1.

Patients undergo follow-up for up to 5 years. Patients experiencing disease progression are followed up every 3 months in years 1 and 2, and then every 6 months for up to 5 years

Inclusion Snapshot

  • Must have histologically confirmed HER2-negative esophageal or gastric cancer
  • Must have oligometastatic disease, which is a type of metastasis in which cancer cells from the original (primary) tumor travel through the body and form a small number of new tumors (metastatic tumors) in one or two other parts of the body

Contact Information

Lankenau Institute for Medical Research trial