NCT01962246

Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction

Phase II Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Concurrent Radiotherapy in Patients With Potentially Resectable Adenocarcinoma of Gastroesophageal Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Hebei Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Stage I：preoperative therapy * Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone ; Stage II: Perioperative therapy * Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to adjuvant Capecitabine plus oxaliplatin alone; * A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal cancer . The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced adenocarcinoma of stomach and gastroesophageal cancer

Conditions

• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Oxaliplatin; Capecitabine	Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation
OTHER	Oxaliplatin; Capecitabine; concurrent radiotherapy	Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for two cycles preoperation , Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation Radiation: radiotherapy 50 Gy in 25 fractions (2Gy /day, 5 days/week,Monday through Friday, ) Other Name: XRT

Timeline

• Start date: 2012-02-01
• Primary completion: 2020-02-01
• Completion: 2021-08-01
• First posted: 2013-10-14
• Last updated: 2022-02-21

Locations

1 site across 1 country: China