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

Primary Purpose

Stomach Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
standard gastrectomy with D2 lymphadenectomy
hyperthermic intraperitoneal chemotherapy
Extensive intraperitoneal lavage
Preoperative chemotherapy
Postoperative chemotherapy
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasm focused on measuring gastric cancer, peritoneal cytology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Gastrointestinal Cancer Center, Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Chemotherapy-first

Surgery-first

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

peritoneal recurrence rate
Recurrence free survival
rate of peritoneal cytology converted to negative
morbidity and mortality of HIPEC and EIPL

Full Information

First Posted
November 12, 2016
Last Updated
November 23, 2016
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT02969122
Brief Title
Treatment Strategy for Stage IV Gastric Cancer With Positive Peritoneal Cytology as the Only Non-curable Factor
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Recruiting
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
Keywords
gastric cancer, peritoneal cytology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy-first
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgery-first
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
standard gastrectomy with D2 lymphadenectomy
Intervention Description
standard distal or total gastrectomy and accorded D2 lymphadenectomy
Intervention Type
Procedure
Intervention Name(s)
hyperthermic intraperitoneal chemotherapy
Other Intervention Name(s)
HIPEC
Intervention Description
Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes
Intervention Type
Procedure
Intervention Name(s)
Extensive intraperitoneal lavage
Other Intervention Name(s)
EIPL
Intervention Description
Lavage of peritoneal cavity with 1000ml saline for 10 times
Intervention Type
Other
Intervention Name(s)
Preoperative chemotherapy
Intervention Description
Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.
Intervention Type
Other
Intervention Name(s)
Postoperative chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
3 year
Secondary Outcome Measure Information:
Title
peritoneal recurrence rate
Time Frame
3 year
Title
Recurrence free survival
Time Frame
3 year
Title
rate of peritoneal cytology converted to negative
Time Frame
7 days After the second time laparoscopic staging and peritoneal cytology examination
Title
morbidity and mortality of HIPEC and EIPL
Time Frame
30 days after HIPEC and EIPL procedures

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rulin Miao, M.D.
Phone
86-10-88196598
Email
miaorulin@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, M.D.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrointestinal Cancer Center, Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rulin Miao, M.D.
Phone
86-10-88196598
Email
miaorulin@outlook.com
First Name & Middle Initial & Last Name & Degree
Jiafu Ji, M.D.
First Name & Middle Initial & Last Name & Degree
Ziyu Li, M.D.
First Name & Middle Initial & Last Name & Degree
Rulin Miao, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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