Clinical trial NCT01836991: D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
Official title: Phase 2 Study of D2 and D2+ Radical Surgery for the Treatment of Advanced Distal Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
surgery
surgery safety
effect
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and the effect of D2 and D2+ radical surgery for the treatment of advanced distal gastric cancer.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the disease-free survival time
timeFrame: 3 years
measure: the overall survival time
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou,
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: xiangdong Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu ZY, Hu C, Chen S, Du YA, Huang L, Yu PF, Wang LJ, Cheng XD. Evaluation of D2-plus radical resection for gastric cancer with pyloric invasion. BMC Surg. 2019 Nov 20;19(1):172. doi: 10.1186/s12893-019-0605-6.
citation: Yu P, Du Y, Xu Z, Huang L, Cheng X. Comparison of D2 and D2 plus radical surgery for advanced distal gastric cancer: a randomized controlled study. World J Surg Oncol. 2019 Feb 6;17(1):28. doi: 10.1186/s12957-019-1572-1.