A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial of Chemotherapy Alone Versus D2 Gastrectomy and Metastasectomy Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
Who is this study for? Patients with distal gastric cancer with one non-curable factor
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
Our study aims to compare the efficacy and safety of Chemotherapy Alone Versus D2 distal gastrectomy and metastasectomy plus Chemotherapy for gastric cancer (GC) with one non-curable Factor
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Lower age limit of research subjects 18 years old and upper age limit of 75 years old.
• PS (ECOG) of 0 or 1.
• Without any other malignancies.
• Written informed consent from the patient.
• Standard gastrectomy with D2 lymphadenectomy for primary cancer
• A single non-curable factor was defined by preoperative CT :
• hepatic metastasis (H1 or H2; maximum diameter ≤4 cm, number ≤4); peritoneal metastasis (R0 or R1 resection) para-aortic lymph node metastasis （number ≤4) ovarian metastasis adrenal metastasis renal metastasis
• No contraindications to chemotherapy, including normal peripheral blood routine, liver and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L)
Locations
Other Locations
China
Anqing Municipal Hospital
RECRUITING
Anqing
Cancer Center of Sun Yat-sen University
RECRUITING
Guangzhou
Yuebei People's Hospital
RECRUITING
Guangzhou
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Jiangxi Provincial Cancer Hospital
RECRUITING
Nanchang
Tianjin Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
First Affiliated Hospital of Wannan Medical College
RECRUITING
Wuhu
Contact Information
Primary
Dazhi Xu, PHD
xudzh@sysucc.org.cn
(+86) 020-87343737
Time Frame
Start Date:2017-12-10
Estimated Completion Date:2025-12-01
Participants
Target number of participants:120
Treatments
Active_comparator: Chemotherapy
chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
Experimental: Surgery+Chemotherapy
D2 Gastrectomy and Metastasectomy + chemotherapy with capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease