Clinical Trial of the Week: Study of radiotherapy added to chemotherapy for certain metastatic GI cancers

By Donna Loyle, communications specialist, LIMR

Clinical trial EA2183 is a new, phase III trial that seeks to establish superiority of consolidative radiation therapy over continuation of chemotherapy 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.

Patients undergo follow-up care for up to 5 years.

Study EA2183 is approved for Lankenau, Bryn Mawr Hospital and Paoli Hospital. The principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. For more, email cancertrials@mlhs.org or visit www.mainlinehealth.org/research/clinical-trials/ea2183

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