This early phase I pilot trial studies how well chemotherapy with or without radiation therapy work in treating patients with gastric cancer who have undergone surgical analysis of the lymph nodes. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, capecitabine, and fluorouracil, 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 beams to kill tumor cells and shrink tumors. It is not yet known whether giving chemotherapy and radiation will work better in treating patients with gastric cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03515941.
PRIMARY OBJECTIVE:
I. To determine the feasibility of patients enrolling and receiving either postoperative chemoradiation or chemotherapy alone, based upon nodal status at surgery, following preoperative chemotherapy.
SECONDARY OBJECTIVES:
I. To evaluate the rate of cancer recurrence in patients assigned to treatment based upon node status.
II. To explore the potential correlation between changes in expression of a pre-specified panel of genes identified as relevant to gastrointestinal cancers in response to preoperative chemotherapy, using presence of nodal involvement at time of surgery as an indicator of response.
OUTLINE: Patients are assigned to 1 of 2 arms.
ARM I: Patients with lymph node negative may receive oxaliplatin intravenously (IV) on day 1 and capecitabine orally (PO) twice daily (BID) on days 1-5, 8-12, and 15-19. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may alternately receive oxaliplatin IV on day 1, leucovorin calcium IV on day 1, fluorouracil IV bolus on day 1, and fluorouracil continuous IV infusion on days 1-3 over 46 hours. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients with lymph node positive receive capecitabine PO BID on days 1-14 or leucovorin calcium IV over 60 minutes, fluorouracil IV bolus on day 1, and fluorouracil over 46 hours on days 1-3. Treatment continues for 14 or 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo radiation therapy 5 days a week and receive capecitabine PO BID or fluorouracil IV on the same days as radiation therapy for 5 weeks. Patients then receive capecitabine PO BID on days 1-14. Treatment repeats every 28 days for 2 cycles absence in the absence of disease progression or unacceptable toxicity. Patients may alternately receive leucovorin calcium IV over 60 minutes, fluorouracil IV bolus on day 1, and fluorouracil over 46 hours on days 1-3. Treatment repeats every 14 days for 2 cycles absence in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 36 months.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorTannaz Armaghany
