Clinical trial NCT01889303: Phase II Study of DC Versus 5-FU/CF as Chemotherapy and Concurrent Chemoradiotherapy for Locally Advanced Gastric Cancer
Official title: Phase II Clinical Trial of Docetaxel Plus Cisplatin as Adjuvant Chemotherapy and Concurrent Chemoradiotherapy Versus FOLFOX6 as Adjuvant and 5-FU/CF as Chemoradiotherapy in Patients of Locally Advanced Gastric Cancer After Radical Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: concurrent chemoradiotherapy
FOLFOX6
chemotherapy
docetaxel
cisplatin
gastric cancer
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 surgical resection. However,there are still many patients experiencing local recurrence or distant metastasis after adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer after resection. The optimal and standard regimen for adjuvant treatment has not been established in locally advanced gastric cancer yet.The investigators designed the trial to investigate the efficacy and safety of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical resection.

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 chemoradiotherapy group had distant relapses. Docetaxel plus cisplatin regimen as adjuvant chemotherapy for gastric cancer has been proofed Safe and Effective in many clinical trials about gastric cancer. The purpose of this study is to evaluate efficacy and safety of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy regimen compared with classical FOLFOX6 regimen as adjuvant chemotherapy and 5-FU/CF as chemoradiotherapy in patients of locally advanced gastric cancer after D2 radical surgery. The investigators hope the new interventions can reduce the rate of distant metastasis and have more clinical benefit.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Age \> 19
3. Histologically proven gastric or gastroesophageal adenocarcinoma
4. ≥ D2 lymph node dissection, curative gastrectomy,
5. Stage T4 with or without any positive LN (AJCC 2010) ，No distant metastasis(M0) and after D2 radical gastrectomy
6. KPS≥70 or ECOG 0-2
7. R0 resection,
8. Adequate bone marrow functions (WBC≥4.0×109/L，GRAN≥2.0×109/L，Hb≥90g/L, transfusion allowed, PLT≥100×109/L )
9. No severe functional damage of major organ,and no uncontrolled or severe cardiopulmonary concurrent system disease
10. 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
11. Predictive survival time longer than 6 months.

Exclusion Criteria:

1. pregnant or breast-feeding women;
2. Have received preoperative neoadjuvant therapy of gastric cancer
3. 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
4. uncontrolled mental disease
5. 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)
6. Active infection requiring antibiotics
7. Resection margin (+) at permanent pathology
8. Peripheral neuropathy symptoms, NCI class \> 1
9. severe malnutrition or severe anemia
10. uncontrolled Primary brain tumors or the central nervous system disease
11. Known hypersensitivity against any of the study drugs
12. Pathologic stage I-IIa or IV (according to AJCC 2010)
13. Inadequate surgery including D0, D1 resection, dissected LNs less than 12
14. Concurrent treatment with other experimental drugs or other anti-cancer therapy, or treatment within a clinical trial within 30 days prior to trial entry

Primary outcomes:
measure: Disease free survival
timeFrame: 2,3 year
Secondary outcomes:
measure: Overall survival(OS)
timeFrame: 3 year
measure: Local and regional control rate
timeFrame: 2,3 year
measure: feasibility (including adverse events )
timeFrame: 3year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: President of Zhongnan Hospital of Wuhan University
name: Y F Zhou, PHD
role: PRINCIPAL_INVESTIGATOR
References: