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Protocol No. EA2183

Principal Investigator Uboha, Nataliya

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Phase III Study of Consolidative Radiotherapy in Patients with Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA)

Objective
The purpose of this study is to compare the usual treatment, which consists of chemotherapy alone, to chemotherapy plus the addition of radiation. The addition of radiation therapy to the usual treatment could stabilize your cancer. But, it could also cause side effects, which are described in the risks section below
This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients by 5 months or more compared to the usual approach

Treatment
You will receive chemotherapy treatment for about four months,your provider will decide to start you on one of two chemotherapy treatments for four months. The two chemotherapy treatment options are FOLFOX(oxaliplatin, leucovorin and 5-fluoropyrimidine (5-FU), or CAPOX(oxaliplatin infusion plus a capecitabine pill), then randomized to Step 2:
Either radiation therapy and continue your chemotherapy treatment, or you will continue to receive chemotherapy treatment alone for up to 2 years

Description Phase III Consolidative radiation in patients with Oligometastatic HER2-Esophageal and Gastric Adenocarcinoma

Key Eligibility
  • 18 years of age or older
  • Must have histologically confirmed HER2 negative metastatic esophageal or gastric adenocarcinoma
  • Must have oligometastatic disease at the time of registration, as defined by the protocol
  • Must not have any contraindications to 5-FU or capecitabine, oxaliplatin
  • Must not have any contraindications to radiation therapy based on consultation with a radiation oncologist
  • ECOG performance status 0-1
  • Can not be pregnant or breastfeeding
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol
  • Must have adequate organ function as defined by the protocol
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must have CD4 > 200 at the time of registration, HIV testing is not required
  • Patients who had prior definitive treatment for early stage EGA with either surgery or chemoradiation are eligible for participation as long as recurrent disease developed at least 6 months after completion of all prior therapies
  • Must not have had any prior treatment with 5-FU or capecitabine and/or oxaliplatin containing systemic therapy
  • Any major surgery must have been completed greater than or equal to 4 weeks prior to registration
  • Known CNS metastasis will be excluded from trial participation, regardless of the status of the CNS disease
  • Must not have any uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Must not have had live vaccines within 30 days prior to registration
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
    Step 2 requirements:
  • Must have histologically confirmed HER2 negative metastatic esophageal or gastric adenocarcinoma with stable disease after 4 cycles of FOLFOX or 6 cycles of CAPOX (Step 1 treatment)
  • Must have no evidence of disease progression based on RECIST criteria since Step 1 registration. Patients with complete radiologic response are eligible for Step 2
  • ECOG performance status 0-1

  • Applicable Disease Sites Esophagus; Stomach

    Status Open

    Participating Institutions Johnson Creek, UW Cancer Center; UW Hospital and Clinics; UWCCC 1 South Park