Status:
UNKNOWN
Chemotherapy Alone Versus Surgery Plus Chemotherapy for Distal Gastric Cancer With One Non-curable Factor
Lead Sponsor:
Sun Yat-sen University
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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
Detailed Description
Gastric cancer is the fourth most common malignancy worldwide and the second leading cause of cancer-related deaths, with the highest mortality rates reported in East Asia, including China. Many patie...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Female in pregnancy or lactation.
- Supraclavicular lymph nodes metastases，lung and bone metastases.
- Massive ascites or cachexia.
- Extensive cancer metastases of liver, peritoneal metastasis,para-aortic lymph node
- Patients participating in any other clinical trails currently，or participated in other trails within 1 months.
- Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- Poor treatment compliance of patients
- The group of chemotherapy alone accepts gastrectomy for bleeding or obstruction
- Failure of R0 or R1 metastasectomy and gastrectomy with D2 lymphadenectomy
Key Trial Info
Start Date :
December 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03399253
Start Date
December 10 2017
End Date
December 1 2025
Last Update
January 16 2018
Active Locations (9)
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1
Anqing Municipal Hospital
Anqing, Anhui, China
2
Anhui Provincial Hospital
Hefei, Anhui, China
3
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
4
First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China