Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Gastric Adenocarcinoma
- Clinical Stage I Gastric Cancer AJCC v8
- Clinical Stage IIA Gastric Cancer AJCC v8
- Postneoadjuvant Therapy Stage I Gastric Cancer AJCC v8
- Pathologic Stage IIIB Gastric Cancer AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage IVA Gastric Cancer AJCC v8
- Postneoadjuvant Therapy Stage II Gastric Cancer AJCC v8
- Pathologic Stage IB Gastric Cancer AJCC v8
- Pathologic Stage II Gastric Cancer AJCC v8
- Pathologic Stage IIA Gastric Cancer AJCC v8
- Pathologic Stage IIB Gastric Cancer AJCC v8
- Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8
- Pathologic Stage IIIC Gastric Cancer AJCC v8
- Pathologic Stage III Gastric Cancer AJCC v8
- Pathologic Stage IIIA Gastric Cancer AJCC v8
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric adenocarcinoma. SECONDARY OBJECTIVES: I. To assess the rate of pathologic complete response (pathCR) in patients treated with preoperative...
PRIMARY OBJECTIVE: I. To assess the safety and tolerability of preoperative short-course chemoradiotherapy (CXRT) in patients with potentially resectable gastric adenocarcinoma. SECONDARY OBJECTIVES: I. To assess the rate of pathologic complete response (pathCR) in patients treated with preoperative short-course CXRT. II. To assess the rate of perioperative complications after gastrectomy in patients treated with preoperative short-course CXRT. III. To assess overall survival from the date of diagnosis in subjects treated with short course CXRT. OUTLINE: Patients receive CXRT consisting of radiation therapy 5 days a week (Monday through Friday) for 2 weeks (10 treatments) and standard of care chemotherapy consisting of capecitabine orally (PO) twice daily (BID) or fluorouracil intravenously (IV) continuous Monday to Friday of each radiation week. About 2 weeks later, patients receive standard of care chemotherapy for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery 3-8 weeks post-chemotherapy completion. After the completion of study treatment, patients are followed up every 6 months for 5 years.
Tracking Information
- NCT #
- NCT04523818
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Brian D Badgwell M.D. Anderson Cancer Center