NCT02240524

Brief Summary

The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.

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
582

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2014

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

First Submitted

Initial submission to the registry

June 3, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

5 years

First QC Date

June 3, 2014

Last Update Submit

September 12, 2014

Conditions

Advanced Gastric Adenocarcinoma

Keywords

Gastric adenocarcinomaHIPECPaclitaxelOxaliplatinCapecitabine

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    From the date of surgery to the date of death or to the end of follow-up

    5 years

Secondary Outcomes (3)

  • Recurrence-free survival

    5 years

  • Locoregional-free survival

    5 years

  • Hepatic metastases-free survival

    5 years

Study Arms (2)

D2 lymphadenectomy and HIPEC and Systemic chemotherapy

EXPERIMENTAL

Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy. HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m\^2, 43°C, 60min. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m\^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m\^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.

Procedure: D2 lymphadenectomyProcedure: Systemic chemotherapyProcedure: HIPEC

D2 lymphadenectomy+Systemic chemotherapy

PLACEBO COMPARATOR

8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m\^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m\^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.

Procedure: D2 lymphadenectomyProcedure: Systemic chemotherapy

Interventions

D2 lymphadenectomyPROCEDURE

The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.

D2 lymphadenectomy and HIPEC and Systemic chemotherapyD2 lymphadenectomy+Systemic chemotherapy
Systemic chemotherapyPROCEDURE
D2 lymphadenectomy and HIPEC and Systemic chemotherapyD2 lymphadenectomy+Systemic chemotherapy
HIPECPROCEDURE
Also known as: hyperthermic intraperitoneal chemoperfusion
D2 lymphadenectomy and HIPEC and Systemic chemotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< age ≤ 65 years old
  • Male or Non pregnant female
  • The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
  • Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan)
  • Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy
  • White blood cells \> 4,000/mm3
  • neutrophils ≥ 1,500/mm3
  • platelets ≥ 100,000/mm3
  • hemoglobin\>9g/l
  • Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN)
  • total bilirubin (TBIL) \< 1.5 times ULN
  • serum creatinine \< 1 times ULN
  • Having given written informed consent prior to any procedure related to the study

You may not qualify if:

  • Existence of macroscopic peritoneal implants
  • Prior malignant tumors with detectable signs of recurrence or distant metastasis
  • Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50%
  • Receiving other cytotoxic chemotherapy
  • High grade of intra-abdominal adhesions
  • Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

RECRUITING

MeSH Terms

Interventions

Neoadjuvant TherapyHyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsChemotherapy, AdjuvantDrug TherapyHyperthermia, Induced

Study Officials

  • shuzhong cui, Ph.D

    Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    STUDY DIRECTOR

Central Study Contacts

zhiyuan fang, Ph.D

CONTACT

86020666736662012fangjnu@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2014

First Posted

September 15, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

September 15, 2014

Record last verified: 2014-09

Locations

CN(1)