Treatment Strategy for Stage IV Gastric Cancer with Positive Peritoneal Cytology As the Only Non-curable Factor
Key facts
- Who runs it
- Peking University
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 59 people, planned
- Started
- Nov 2016
- Ended
- 9 Sept 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- standard gastrectomy with D2 lymphadenectomy
- hyperthermic intraperitoneal chemotherapy
- Extensive intraperitoneal lavage
- Preoperative chemotherapy
- Postoperative chemotherapy
- Record updated
- 19 September 2024
- Why it stopped
- Not enough cases enrolled in the study.
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Organ transplantation patients who needs immune suppression therapy
- Remnant gastric cancer, recurrence gastric cancer or multi-primary cancers
- 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
- Patients who needs emergency surgery because of bleeding, perforation or obstruction
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Chemotherapy-firstExisting treatment, for comparison
Patients will receive hyperthermic intraperitoneal chemotherapy (HIPEC) during laparoscopic staging. Then 3 cycles of preoperative chemotherapy and clinical evaluation of chemotherapy will be performed. If the patient's disease is evaluated as progressed, the patient will receive systemic therapy. If it's stable or remission, a second time laparoscopic staging and peritoneal cytology examination will be performed. If peritoneal implant is observed, the patients will receive systemic therapy. If the peritoneal cytology is still positive, the treatment will be decided according to the suggestion of MDT discussion. If the peritoneal cytology is converted negative, standard gastrectomy with D2 lymphadenectomy and extensive intraperitoneal lavage (EIPL) will be performed. Postoperative chemotherapy will be determined according to the pathological evaluation of preoperative chemotherapy response.
Treatment: standard gastrectomy with D2 lymphadenectomy, hyperthermic intraperitoneal chemotherapy, Extensive intraperitoneal lavage, Preoperative chemotherapy, and Postoperative chemotherapy
- Surgery-firstTreatment being tested
Patients in this arm will receive standard gastrectomy with D2 lymphadenectomy after randomization. Hyperthermic intraperitoneal chemotherapy (HIPEC) and extensive intraperitoneal lavage (EIPL) will be applied before abdominal closure. After surgery, 8 cycles of postoperative chemotherapy will be performed.
Treatment: standard gastrectomy with D2 lymphadenectomy, hyperthermic intraperitoneal chemotherapy, Extensive intraperitoneal lavage, and Postoperative chemotherapy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 19 September 2024