NCT02969122

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

7.9 years

First QC Date

November 12, 2016

Last Update Submit

September 13, 2024

Conditions

Stomach Neoplasm

Keywords

gastric cancerperitoneal cytology

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 year

Secondary Outcomes (4)

  • peritoneal recurrence rate

    3 year

  • Recurrence free survival

    3 year

  • rate of peritoneal cytology converted to negative

    7 days After the second time laparoscopic staging and peritoneal cytology examination

  • morbidity and mortality of HIPEC and EIPL

    30 days after HIPEC and EIPL procedures

Study Arms (2)

Chemotherapy-first

ACTIVE COMPARATOR

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 lymphadenectomyProcedure: hyperthermic intraperitoneal chemotherapyProcedure: Extensive intraperitoneal lavageOther: Preoperative chemotherapyOther: Postoperative chemotherapy

Surgery-first

EXPERIMENTAL

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 lymphadenectomyProcedure: hyperthermic intraperitoneal chemotherapyProcedure: Extensive intraperitoneal lavageOther: Postoperative chemotherapy

Interventions

standard gastrectomy with D2 lymphadenectomyPROCEDURE

standard distal or total gastrectomy and accorded D2 lymphadenectomy

Chemotherapy-firstSurgery-first
hyperthermic intraperitoneal chemotherapyPROCEDURE

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

Also known as: HIPEC
Chemotherapy-firstSurgery-first
Extensive intraperitoneal lavagePROCEDURE

Lavage of peritoneal cavity with 1000ml saline for 10 times

Also known as: EIPL
Chemotherapy-firstSurgery-first
Preoperative chemotherapyOTHER

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

Chemotherapy-first
Postoperative chemotherapyOTHER

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.

Chemotherapy-firstSurgery-first

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrointestinal Cancer Center, Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • Jiafu Ji, M.D.

    Peking University Cancer Hospital & Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of Peking University Cancer Hospital

Study Record Dates

First Submitted

November 12, 2016

First Posted

November 21, 2016

Study Start

November 1, 2016

Primary Completion

September 9, 2024

Study Completion

September 9, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)