Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well chemotherapy with or without radiation or surgery works in treating participants with esophageal or gastric cancer that has spread to less than 3 places in the body (oligometastatic). Drugs used in chemotherapy, such as fluorouracil 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Surgery, such as complete surgical resection, may stop the spread of tumor cells by surgically removing organs or tumors. Giving chemotherapy with radiation or surgery may work better than chemotherapy alone in treating participants with oligometastatic esophageal or gastric cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Fluorouracil

Criteria

Inclusion Criteria:

• The patient has a pathologic diagnosis of tumor biopsy or fine needle aspiration (FNA) of esophageal or gastric cancer of adenocarcinoma histology

• The patient is staged with endoscopic ultrasound (EUS)/esophago-gastro-duodenoscopy (EGD) and positron emission tomography (PET)/computed tomography (CT) scan

• The patient has three or less observable metastatic lesions. Metastatic lesions include distant M1 lymph node group; which will be counted as one site (M1 metastatic lymph nodes to include cervical, mediastinal, gastric, retroperitoneal lymph nodes will be counted as one lesion). Osseous metastases or visceral metastases will each count as one metastatic site. Each central nervous system (CNS) metastases will count as one metastatic site. Satellite lesions in the primary esophageal malignancy such as skipped esophageal primaries are not considered metastatic sites. Symptomatic metastatic sites can be treated locally prior to randomization or by palliative radiation

• Patient Eastern Cooperative Oncology Group (ECOG) of 0-2, with life expectancy of at least 6 months

• Participants signed informed consent

• Women of child bearing age must have pregnancy test at time of enrollment, agree to use of adequate contraception (birth control hormone or barrier method) for the duration of the study and for six months after discontinuation of systemic agents

Exclusion Criteria:

• Patients with prior chemotherapy or radiation therapy for their diagnosis of esophageal or gastric cancer. Patients with prior radiation therapy to same site for another diagnosis of cancer. Note: Patients may receive palliative radiation to their symptomatic sites of metastases but not definitive local therapy to esophageal or gastric primary prior to randomization. All patients may be enrolled on protocol then start systemic therapy; if they do not have evidence of disease progression at re-staging following initial therapy, they may be randomized

• Patients with fistula documented radiographically or by EDG/EUS, endobronchial ultrasound (EBUS)

• Patients with life expectancy less than 6 months, ECOG > 3

• Female patients who are pregnant confirmed by beta human chorionic gonadotropin (bHCG) laboratory (lab) test

• Patient has history of uncontrolled angina, congestive heart failure or recent myocardial infarction (MI) within 6 months