Treatment Strategy for Stage IV Gastric Cancer With Positive Peritoneal Cytology as the Only Non-curable Factor

Stomach Neoplasm Clinical Trial

— Cy-plus  

Official title:

Treatment Strategy for Stage IV Gastric Cancer With Positive Peritoneal Cytology as the Only Non-curable Factor (Cy-plus): a Phase 2, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02969122
• Other study ID #: 2016YJZ35
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2016
• Last updated: November 23, 2016
• Start date: November 2016
• Est. completion date: December 2023

Study information

• Verified date: November 2016
• Source: Peking University
• Contact: Rulin Miao, M.D.
• Phone: 86-10-88196598
• Email: miaorulin[@]outlook.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Gastric cancer with positive is defined as stage IV disease in 7th AJCC/UICC TNM staging system. Controversy exists on the treatment of this part of patients. This trial aimed to explore the optimal treatment strategy for stage IV gastric cancer with positive peritoneal cytology as the only non-curable factor.

Description:

In the 7th AJCC/UICC TNM staging system, gastric cancer with positive peritoneal cytology (CY+) is defined as stage IV disease. In NCCN clinical practice guidelines, it is suggested that positive peritoneal cytology in the absence of visible peritoneal implants should be considered as M1 disease and surgery as initial treatment is not recommended for patients with positive peritoneal cytology. However, in the Japanese gastric cancer treatment guidelines 2014, it is suggested that standard gastrectomy can be proposed for patients with no other non-curative factors and if the CY+ status was revealed after surgery, postoperative treatment with S-1 can be recommended as the tentative standard. Previous studies have also proved that extensive intraperitoneal lavage(EIPL) and Hyperthermic Intraperitoneal Chemotherapy(HIPEC) are effective methods for the treatment of peritoneal metastasis.

In order to optimize the treatment strategy of this part of patients, this trial is designed to compare the effectiveness of 2 treatment strategies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pathologically diagnosed gastric adenocarcinoma with endoscopic biopsy;

• Pretreatment clinical stage with computed tomography and/or endoscopic ultrasonography;

• Clinical stage cT2-4 N0-3 M0;

• Standard gastrectomy with D2 lymphadenectomy is needed according to the clinicians' evaluation;

• ECOG performance score =2, with tolerance of standard gastrectomy and D2 lymphadenectomy;

• Positive peritoneal cytology;

• Signed informed consent.

Exclusion Criteria:

• Remnant gastric cancer, recurrence gastric cancer or multi-primary cancers;

• Intraoperative identified other unresectable factors including other metastasis except positive peritoneal cytology;

• Postoperative pathologically diagnosed as non adenocarcinoma;

• Pregnant or lactate women;

• Child-bearing period adults who refuse to birth control during the trial;

• Uncontrolled epilepsy, CNS disease or mental disorder that may influence the compliance of the patient;

• Severe/active heart disease, including but not limited to acute coronary syndrome, congestive heart failure with less than NYHA II cardiac function, severe arrhythmia that needs drug control, cardiac infarction within 12 month;

• Organ transplantation patients who needs immune suppression therapy;

• Patients who needs emergency surgery because of bleeding, perforation or obstruction.

Study Design

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

Related Conditions & MeSH terms

• Stomach Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• standard gastrectomy with D2 lymphadenectomy
standard distal or total gastrectomy and accorded D2 lymphadenectomy
• hyperthermic intraperitoneal chemotherapy
Intraperitoneal docetaxel of 100mg/m2 at 42? for 30 minutes
• Extensive intraperitoneal lavage
Lavage of peritoneal cavity with 1000ml saline for 10 times

Other:
• Preoperative chemotherapy
Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.
• Postoperative chemotherapy
SOX regimen postoperative chemotherapy (Oxaliplatin 130mg/m2 D1, S-1 40-60mg Bid D1-14, Repeated every 3 weeks) for surgery-first arm. Regimen for chemotherapy-first arm is determined according to the postoperative pathologic evaluation of response.

Locations

Country	Name	City	State
China	Gastrointestinal Cancer Center, Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 year	No
Secondary	peritoneal recurrence rate		3 year	No
Secondary	Recurrence free survival		3 year	No
Secondary	rate of peritoneal cytology converted to negative		7 days After the second time laparoscopic staging and peritoneal cytology examination	No
Secondary	morbidity and mortality of HIPEC and EIPL		30 days after HIPEC and EIPL procedures	Yes