NCT03161522

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

A Randomized Trial Comparing Early Local Chemoradiation Therapy +/- Surgery Versus Systemic Therapy for Patients With Esophageal or Gastric Cancer With Oligometastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 chemotherapy for a minimum of 6 cycles and a maximum of 8 cycles in the absence of disease progression or unacceptable toxicity. Participants are then randomized to 1 of 2 groups. GROUP I (MAINTENANCE CHEMOTHERAPY): Participants receive fluorouracil and capecitabine per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. GROUP II (LOCAL THERAPY): Participants receive fluorouracil and capecitabine and undergo radiation therapy (RT) per instructions of the treating physician in the absence of disease progression or unacceptable toxicity. Participants may also undergo surgery to some or all of the remaining sites of disease as is clinically prudent and indicated by treating physician. After completion of study treatment, participants are followed up at 4-8 weeks, 2-3 months, every 3-6 months for up to 3 years, and then every 6-12 months thereafter.

Conditions

• Gastric Adenocarcinoma
• Oligometastasis
• Stage IV Esophageal Adenocarcinoma AJCC v7
• Stage IV Esophageal Cancer AJCC v7
• Stage IV Gastric Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Capecitabine	Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
DRUG	Chemotherapy	Receive induction chemotherapy
PROCEDURE	Conventional Surgery	Undergo surgery
DRUG	Fluorouracil	Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
RADIATION	Radiation Therapy	Undergo RT

Timeline

• Start date: 2018-02-19
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2017-05-19
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study