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

NCT ID: NCT02969122

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2024-09-09

Brief 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.

Detailed 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.

Conditions

Stomach Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy-first

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.

Group Type: ACTIVE_COMPARATOR

standard gastrectomy with D2 lymphadenectomy

Intervention Type: PROCEDURE

standard distal or total gastrectomy and accorded D2 lymphadenectomy

hyperthermic intraperitoneal chemotherapy

Intervention Type: PROCEDURE

Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes

Extensive intraperitoneal lavage

Intervention Type: PROCEDURE

Lavage of peritoneal cavity with 1000ml saline for 10 times

Preoperative chemotherapy

Intervention Type: OTHER

Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.

Postoperative chemotherapy

Intervention Type: OTHER

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.

Surgery-first

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.

Group Type: EXPERIMENTAL

standard gastrectomy with D2 lymphadenectomy

Intervention Type: PROCEDURE

standard distal or total gastrectomy and accorded D2 lymphadenectomy

hyperthermic intraperitoneal chemotherapy

Intervention Type: PROCEDURE

Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes

Extensive intraperitoneal lavage

Intervention Type: PROCEDURE

Lavage of peritoneal cavity with 1000ml saline for 10 times

Postoperative chemotherapy

Intervention Type: OTHER

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.

Interventions

standard gastrectomy with D2 lymphadenectomy

standard distal or total gastrectomy and accorded D2 lymphadenectomy

Intervention Type: PROCEDURE

hyperthermic intraperitoneal chemotherapy

Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes

Intervention Type: PROCEDURE

Extensive intraperitoneal lavage

Lavage of peritoneal cavity with 1000ml saline for 10 times

Intervention Type: PROCEDURE

Preoperative chemotherapy

Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

HIPEC; EIPL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jiafu Ji

President of Peking University Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiafu Ji, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Gastrointestinal Cancer Center, Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2016YJZ35

Identifier Type: -

Identifier Source: org_study_id