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Phase 2 Study of D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer


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

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Trial Information

Phase 2 Study of D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer


To evaluate the safety and the disease-free survival time(DFS) and overall survival time(OS)
of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.


Inclusion Criteria:



- Male and female aged 18 to 70 years old.

- The preoperative evaluation: distal gastric cancer patients, ≥ T2 or N +; or staging
II, IIIA, IIIB.

- Karnofsky score ≥ 70, life expectancy > 6 months.

- Endoscopic biopsy diagnosis of gastric cancer, excluding non-Hodgkin's lymphoma,
leiomyosarcoma and other mesenchymal tumors.

- the blood and biochemical indicators of the subjects must meet the following
criteria: Hb ≥ 9 g / dl; WBC ≥ 4,000 / mm3, ≤ 12000 / mm3; PLT ≥ 100,000/mm3;

- GOT, GPT within twice the institutional limit,serum total bilirubin < 1.5 times the
upper limit of normal, serum creatinine< 1.25 times the upper limit of normal

- have not received prior chemotherapy, radiotherapy and biological therapy. signed
informed consent.

- must accept the standard D2 or D2 + radical gastrectomy.

- with good compliance.

Exclusion Criteria:

- pregnancy, breast-feeding women.

- allergy with chemotherapy drugs or metabolic disorder.

- the history of organ transplants (including bone marrow transplantation and
autologous peripheral stem cell transplantation).

- had long received systemic steroid treatment (Note: short-term users of withdrawal >
2 weeks can be selected.)

- The existence of the peripheral nervous system disorders or significant neurological
disorders and a history of central nervous system disorders.

- patients with severe infection requires treatment.

- patients associated with dysphagia, active peptic ulcer, incompleteness intestinal
obstruction, active gastrointestinal bleeding, perforation.

severe liver disease (such as cirrhosis), kidney disease, respiratory disease or
uncontrollable diabetes.

- with other malignancies which were not cured.

- EKG abnormalities or heart disease with apparent clinical symptoms, including
congestive heart failure, coronary heart disease with symptoms, uncontrollable
arrhythmia, hypertension, and heart attack within 12 months or III or IV grade
myocardial infarction. Coronary heart disease with symptoms, uncontrollable
arrhythmia, hypertension, and heart attack within 12 months or III or IV grade
myocardial infarction.

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:

the disease-free survival time

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

xiangdong Cheng

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

RS-ADGC

NCT ID:

NCT01836991

Start Date:

January 2012

Completion Date:

January 2017

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • surgery
  • surgery safety
  • effect
  • Stomach Neoplasms

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