A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases
M.D. Anderson Cancer Center
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.
Description
PRIMARY OBJECTIVES: I. To evaluate whether esophageal or gastric patients with oligometastatic cancer without disease progression after first line chemotherapy therapy will demonstrate improved overall survival (OS) with early local therapy (concurrent chemotherapy/radiation and surgery). SECONDARY OBJECTIVES: I. Assess the relationships between progression-free survival and overall survival between both treatment arms. II. Report local control, loco-regional control. III. Report time to progression of distant metastases. IV. Report toxicity. OUTLINE: Participants receive induction chemo…
Eligibility
- Age range
- 18–79 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The patient has a pathologic diagnosis of tumor biopsy or FNA of esophageal or gastric cancer of adenocarcinoma histology * The patient is staged with EGD and PET/CT scan. * The patient has three or less observable metastatic lesions. Patients may have three or less radiographically visible metastatic lesions at diagnosis or if have regressed to three or less metastatic lesions after induction chemotherapy at time of randomization. The patient must have pathologic confirmation and or radiologically visible disease. For esophageal tumors, the maximal dimension of the prim…
Interventions
- DrugCapecitabine
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
- DrugChemotherapy
Receive induction chemotherapy
- ProcedureConventional Surgery
Undergo surgery
- DrugFluorouracil
Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
- RadiationRadiation Therapy
Undergo RT
Location
- M D Anderson Cancer CenterHouston, Texas