Status:
UNKNOWN
Phase II Study of DC Versus 5-FU/CF as Chemotherapy and Concurrent Chemoradiotherapy for Locally Advanced Gastric Cancer
Lead Sponsor:
Wuhan University
Conditions:
Gastric Cancer
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
Brief Summary
Concurrent chemoradiotherapy has been demonstrated a significant improvement in overall survival and disease-free survival according to Intergroup Trial 0116 in patients with gastric cancer after surg...
Detailed Description
In Intergroup 0116 trial, 5-FU plus CF regimen was used as adjuvant chemotherapy and concurrent chemoradiotherapy in patients with resected gastric cancer.But 33 percent of those in the chemoradiother...
Eligibility Criteria
Inclusion
- Written informed consent
- Age \> 19
- Histologically proven gastric or gastroesophageal adenocarcinoma
- ≥ D2 lymph node dissection, curative gastrectomy,
- Stage T4 with or without any positive LN (AJCC 2010) ，No distant metastasis(M0) and after D2 radical gastrectomy
- KPS≥70 or ECOG 0-2
- R0 resection,
- Adequate bone marrow functions (WBC≥4.0×109/L，GRAN≥2.0×109/L，Hb≥90g/L, transfusion allowed, PLT≥100×109/L )
- No severe functional damage of major organ,and no uncontrolled or severe cardiopulmonary concurrent system disease
- Adequate renal functions(serum creatinine ≤ 1.5×ULN ) ;liver functions (serum bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.5 times(normal value) ,serum AKP≤2.5×ULN
- Predictive survival time longer than 6 months.
Exclusion
- pregnant or breast-feeding women;
- Have received preoperative neoadjuvant therapy of gastric cancer
- Before or at the same time with other malignant tumor, and underwent chemotherapy, immune, and biological treatment and radiation therapy;with the exception of adequately treated cervical carcinoma in situ or localized non-melanoma skin cancer
- uncontrolled mental disease
- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, no myocardial infarction within the last 12 months, unstable angina pectoris, or significant arrhythmia)
- Active infection requiring antibiotics
- Resection margin (+) at permanent pathology
- Peripheral neuropathy symptoms, NCI class \> 1
- severe malnutrition or severe anemia
- uncontrolled Primary brain tumors or the central nervous system disease
- Known hypersensitivity against any of the study drugs
- Pathologic stage I-IIa or IV (according to AJCC 2010)
- Inadequate surgery including D0, D1 resection, dissected LNs less than 12
- Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01889303
Start Date
May 1 2013
End Date
December 1 2023
Last Update
February 14 2022
Active Locations (1)
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1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071