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

November 23, 2016 updated by: Jiafu Ji, Peking University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Gastrointestinal Cancer Center, Peking University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Procedure: standard gastrectomy with D2 lymphadenectomy
standard distal or total gastrectomy and accorded D2 lymphadenectomy
Procedure: hyperthermic intraperitoneal chemotherapy
Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes
Other Names:
  • HIPEC
Procedure: Extensive intraperitoneal lavage
Lavage of peritoneal cavity with 1000ml saline for 10 times
Other Names:
  • EIPL
Other: Preoperative chemotherapy
Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.
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.
EXPERIMENTAL: 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.
Procedure: standard gastrectomy with D2 lymphadenectomy
standard distal or total gastrectomy and accorded D2 lymphadenectomy
Procedure: hyperthermic intraperitoneal chemotherapy
Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes
Other Names:
  • HIPEC
Procedure: Extensive intraperitoneal lavage
Lavage of peritoneal cavity with 1000ml saline for 10 times
Other Names:
  • EIPL
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
peritoneal recurrence rate
Time Frame: 3 year
3 year
Recurrence free survival
Time Frame: 3 year
3 year
rate of peritoneal cytology converted to negative
Time Frame: 7 days After the second time laparoscopic staging and peritoneal cytology examination
7 days After the second time laparoscopic staging and peritoneal cytology examination
morbidity and mortality of HIPEC and EIPL
Time Frame: 30 days after HIPEC and EIPL procedures
30 days after HIPEC and EIPL procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

November 12, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (ESTIMATE)

November 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YJZ35

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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