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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


Phase 2
19 Years
70 Years
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Description:

efficacy of docetaxel plus cisplatin regimen as adjuvant chemotherapy and concurrent chemoradiotherapy for locally advanced gastric cancer patients in this trial is defined as 2 or 3 year disease free survival

Outcome Time Frame:

2,3 year

Safety Issue:

No

Principal Investigator

Y F Zhou, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

President of Zhongnan Hospital of Wuhan University

Authority:

China: Food and Drug Administration

Study ID:

HCCSC G-02

NCT ID:

NCT01889303

Start Date:

May 2013

Completion Date:

June 2016

Related Keywords:

  • Gastric Cancer
  • concurrent chemoradiotherapy
  • FOLFOX6
  • chemotherapy
  • docetaxel
  • cisplatin
  • gastric cancer
  • Stomach Neoplasms

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