NCT02205008

Brief Summary

Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published. In this study, we review the clinicopathological characteristics of patients and effects of early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric cancer-specific survival and patterns of recurrence of gastric cancer patients with macroscopic serosal invasion. The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall and disease free survival of advanced gastric cancer patients with serosal invasion after potentially curative surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

3.2 years

First QC Date

July 26, 2014

Last Update Submit

July 29, 2014

Conditions

Advanced Gastric Cancer With Serosal Invasion

Keywords

advanced gastric cancerserosal invasionperitoneal recurrenceintraperitoneal chemotherapy

Outcome Measures

Primary Outcomes (1)

  • relapsed free survival

    during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded

    postoperative 3 years

Secondary Outcomes (1)

  • overall survival

    postoperative 5 years

Other Outcomes (1)

  • surgery and intraperitoneal chemotherapy-related morbidity and mortality

    postoperative 30days

Study Arms (2)

Arm A

ACTIVE COMPARATOR

curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1

Procedure: surgeryDrug: adjuvant systemic chemotherapyDrug: Early postoperative intraperitoneal chemothgerapy

Arm B

PLACEBO COMPARATOR

curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1

Procedure: surgeryDrug: adjuvant systemic chemotherapy

Interventions

surgeryPROCEDURE

Total or subtotal gastrectomy with D2

Arm AArm B
adjuvant systemic chemotherapyDRUG

adjuvant systemic chemotherapy with S-1 (\<1.25m2:40mg, 1.25-1.5m2:50mg, \>1.5m2:60mg, bid)

Arm AArm B
Early postoperative intraperitoneal chemothgerapyDRUG

operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2 1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq

Arm A

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven adenocarcinoma of the stomach
  • preoperative suspicion of serosal invasion on the radiological examination
  • candidate for curative resection of the stomach with D2
  • age from 19 to 70 year old
  • Eastern Cooperative Oncology Group Performance status :0, 1, or 2
  • absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dL, and platelet≥100,000/microliter
  • serum Creatinine\<1.5mg/dL
  • total bilirubin \<2 x upper normal limit, transaminase\<3 x upper normal limit
  • patients without previous administration of chemotherapeutic agent
  • patients who agreed and signed to the informed consent form

You may not qualify if:

  • malignancy of the stomach except for adenocarcinoma
  • history of hypersensitivity to 5-fluorouracil or mitomycin
  • concomitant infectious disease
  • active hepatitis or chronic liver disease
  • history of psychotic disorders
  • patients with disorders in the central nervous system
  • history of other malignancy within 5 years
  • history of clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, symptomatic arrhythmia, myocardial infarction)
  • patients with increased bleeding tendency
  • pregnant or lactating female patients
  • patient who did not agreed and signed to the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Medical Center Gastric Cancer Center

Daegu, 702-210, South Korea

RECRUITING

Related Publications (1)

  • 1. Maruyama K, Okabayashi K, Kinoshita T. Progress in gastric cancer surgery in Japan and its limits of radicality. World J Surg 1987;11:418-425. 2. Lee JL, Kang HJ, Kang YK, et al. Phase I/II study of 3-week combination of S-1 and cisplatin chemotherapy for metastatic or recurent gastric cancer. Cancer Chemother Pharmacol 2007 (E-pub). 3. Schoffski P. The modulated oral fluoropyrimidine prodrug S-1, and its use in gastrointestinal cancer and other solid tumors. Anticancer Drug 2004;15:85-106. 4. Sugimachi K, Maehara Y, Horikoshi N et al. An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 1999;57:202-210. 5. Koizumi W, Kurihara M, Nakajo S et al. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology 2000;58:191-197. 6. Sakata Y, Ohtsu A, Horikoshi N et al. Late phase II study of novel oral fluoropyrimidine anticancer drugs S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715-1720. 7. Nagashima F, Ohtsu A, Yoshida S et al. Japanese nationwide postmarketing survey of S-1 in patients with advanced gastric cancer. Gastric Cancer 2005;8:6-11. 8. Chollet P, Schoffski P, Weigang-Kohler K et al. Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC early clinical studies group (ECGC). Eur J Cancer 2003;39:1264-1270. 9. Ilson D. Just when you thought the fluorouracil debate was over: S-1 and gastric cancer. J Clin Oncol 2005;23:6826-6828. 10. Hoff PM, Saad ED, Ajani JA et al. Phase I study with pharmacokinetics of S-1, an oral daily schedule for 28 days in patients with solid tumors. Clin Cancer Res 2003;9:134-142. 11. Simon R. Optimal two-stage design for phase II clinical trials. Controlled Clin Trials 1989;10:1-10.

    BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Wansik Yu, MD. PhD

    Kyungpook National University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wansik Yu, MD, PhD, FACS

CONTACT

82-53-200-2700wyu@knu.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 26, 2014

First Posted

July 31, 2014

Study Start

October 1, 2012

Primary Completion

December 1, 2015

Study Completion

November 1, 2018

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

KR(1)