Stomach Neoplasm Clinical Trial
— Cy-plusOfficial 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
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Gastrointestinal Cancer Center, Peking University Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
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 |
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