NCT02356276

Brief Summary

HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.

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
584

participants targeted

Target at P50-P75 for phase_3 gastric-cancer

Timeline
Completed

Started May 2015

Typical duration for phase_3 gastric-cancer

Geographic Reach
1 country

14 active sites

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

January 29, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2015

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

6.6 years

First QC Date

January 29, 2015

Last Update Submit

October 29, 2017

Conditions

Gastric Cancer

Keywords

locally advanced gastric cancerHyperthermic Intraperitoneal Chemotherapyradical gastrectomy with D2 lymphadenectomy

Outcome Measures

Primary Outcomes (1)

  • 5-year overall survival

    assess overall survival during 5 years in both study arms

    5 years

Secondary Outcomes (4)

  • 5-year progression-free survival

    5 years

  • liver metastatic rate

    5 years

  • local recurrence rate

    5 years

  • side effects

    5 years

Other Outcomes (1)

  • CEA mRNA expression of peritoneal lavage fluid

    Through study completion, an average of 3 year

Study Arms (2)

HIPEC group

EXPERIMENTAL

Postoperative hyperthermic intraperitoneal chemotherapy (HIPEC) is performed after radical surgery, followed by 6-8 cycles of systemic chemotherapy. The first HIPEC is conducted within 48 h after surgery: Paclitaxel 75 mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min. Systemic chemotherapy (XELOX or SOX regimens): XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles. If XELOX regimen is not conducted in some collaborators, SOX regimen is also permitted. The regimen is Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid, po, day 1-14, every 3 weeks for a total of 6-8 cycles.

Procedure: D2 lymphadenectomyProcedure: Hyperthermic Intraperitoneal ChemotherapyDrug: Systemic chemotherapy (XELOX or SOX regimens)

Control group

PLACEBO COMPARATOR

6-8 cycles of systemic chemotherapy (XELOX or SOX regimens) were performed after radical gastrectomy with D2 lymphadenectomy. XELOX regimen is Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles. If XELOX regimen is not conducted in some collaborators, SOX regimen as comment systemic chemotherapy in Asia is also permitted to treat the patients. The treatment bundles are listed as follows: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid), po, day 1-14, every 3 weeks for a total of 6-8 cycles.

Procedure: D2 lymphadenectomyDrug: Systemic chemotherapy (XELOX or SOX regimens)

Interventions

D2 lymphadenectomyPROCEDURE
Also known as: surgical resection or radical surgery
Control groupHIPEC group
Hyperthermic Intraperitoneal ChemotherapyPROCEDURE

The first HIPEC is conducted within 48 h after surgery: Normal saline 3000 -4000ml, Paclitaxel 75mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min.

Also known as: HIPEC
HIPEC group
Systemic chemotherapy (XELOX or SOX regimens)DRUG

XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles. SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40 mg/m\^2 bid, po, day 1-14 (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid) bid, d1-14, po, every 3 weeks for a total of 6-8 cycles.

Also known as: XELOX or SOX regimens
Control groupHIPEC group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< age ≤ 70 years old
  • Male or Non pregnant female
  • The Eastern Cooperative Oncology Group (ECOG) status 0-1
  • T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7th edition)
  • No distance metastasis, eligible for D2 lymphadenectomy
  • 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:

  • Have other cancer within 5 years
  • Existence of distance metastasis during surgey (M1)
  • 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%
  • Epileptic seizures patients need medicine control
  • Uncontroled mental disease or mental disorder
  • Drug abuse or psychological or social factors affect the judgment of results
  • Contraindication to any therapy contained in this regimen specific to the study
  • Receiving other chemotherapy, radiotherapy or immunotherapy
  • Without given written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Affiliated Tumor Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

RECRUITING

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050011, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Wuhan Union Hospital, China

Wuhan, Hubei, 430030, China

RECRUITING

The second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Zhejiang Cancer Hospital

Hanzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Hyperthermic Intraperitoneal ChemotherapyXELOX

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • shuzhong cui, M.D

    Affiliated Tumor Hospital of Guangzhou Medical University Recruiting

    STUDY DIRECTOR

Central Study Contacts

shuzhong cui, M.D

CONTACT

0086-138-0251-3800cuishuzhong@126.com

Xian-Zi Yang, M.M

CONTACT

0086-188-9853-41677097359@qq.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

January 29, 2015

First Posted

February 5, 2015

Study Start

May 11, 2015

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

October 31, 2017

Record last verified: 2017-10

Locations

CN(14)