Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastric Adenocarcinoma
- Oligometastasis
- Stage IV Esophageal Adenocarcinoma AJCC v7
- Stage IV Esophageal Cancer AJCC v7
- Stage IV Gastric Cancer AJCC v7
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 79 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03161522
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Quynh-Nhu Nguyen M.D. Anderson Cancer Center