NCT02960061

Brief Summary

The investigators intend to conduct a randomized controlled study to find if combining HIPEC (hyperthermic intraperitoneal perfusion chemotherapy) with post-neoadjuvant chemotherapy D2 resection could improve survival for patients with advanced gastric cancer, while comparing with the traditional approach of D2 resection after neoadjuvant chemotherapy.

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
640

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2016

Typical duration 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

November 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 9, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

November 3, 2016

Last Update Submit

November 8, 2016

Conditions

Survival

Keywords

Intraperitoneal chemotherapygastric cancerNeo-adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Number of survival participants will be assessed according to the data collected by the followed up office.

    1-5 years

Secondary Outcomes (1)

  • Progression Free Survival

    1-3 years

Study Arms (2)

HIPEC

EXPERIMENTAL

After receiving neoadjuvant chemotherapy and D2 radical resection, Hyperthermic intraperitoneal perfusion chemotherapy is conducted,4 catheters are placed in 4 position in the peritoneal cavity: ① under the left diaphragm ② hepatorenal recess ③ left pelvis ④ right pelvis.catheters, all four tubes are connected to the perfusion device.Perfusion prescription: cycle 1, Paclitaxel 75mg/ m2 diluted with 3000ml normal saline heated up to a fixed temperature of 43°C circulate continuously for 60min at a speed of 400-500ml/h; cycle 2 start within 24-48 hours after cycle 1, dosage of paclitaxel adjust to 100mg/ m2, the rest of the same. A total of two cycle is administered, routine adjuvant chemotherapy using SOX (oxaliplatin plus S-1 capsule)or XELOX regimens follows within 4-6 weeks.

Drug: Neoadjuvant chemotherapyProcedure: D2 radical resectionDrug: Hyperthermic intraperitoneal perfusion chemotherapyDrug: Adjuvant chemotherapy

controlled group

SHAM COMPARATOR

After receiving neoadjuvant chemotherapy and D2 radical resection, patients receive peritoneal lavage with 3000ml distilled water.Adjuvant chemotherapy using SOX or XELOX regimens is administered as routine within 4-6 weeks.

Drug: Neoadjuvant chemotherapyProcedure: D2 radical resectionDrug: Adjuvant chemotherapy

Interventions

Neoadjuvant chemotherapyDRUG

Eligible patients receive 4 cycles of mDOF(docetaxel 50 mg/ m2 day 1 + oxaliplatin 85 mg/ m2 day 2 + fluorouracil 400 mg/ m2 bolus iv followed by 600 mg/ m2 22 hours chronic infusion, day 2/3 + leucovorin 200 mg/ m2, day2/3; repeated every 14 days ).

HIPECcontrolled group
D2 radical resectionPROCEDURE

Laparotomy or laparoscopic surgery are chosen according to the preference of the surgeon. Either cases, a throughout peritoneal cavity exploration is required to comfirmed the tumor resectability and peritoneal metastasis. A curative D2 resection is performed if achievable.

HIPECcontrolled group
Hyperthermic intraperitoneal perfusion chemotherapyDRUG

Two cycle of hyperthermic intraperitoneal perfusion chemotherapy is administered to patients who have received neoadjuvant chemotherapy and D2 resection, dosage and the relative parameter setting is described above.

HIPEC
Adjuvant chemotherapyDRUG

Adjuvant chemotherapy using SOX or XELOX regimen will be administered as routine within 4-6 weeks.

HIPECcontrolled group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First diagnosed as gastric cancer by pathological examination;
  • No previous chemotherapy or radiotherapy;
  • T stage:3-4, N stage: 1-3, M stage: 0, assessed by CT or ultrasound endoscope;
  • Eastern Cooperative Oncology Group performance status (ECOG PS): 0-1;
  • Informed consent signed;

You may not qualify if:

  • Other malignancy within 5 years.
  • Peritoneal metastasis detected during surgery.
  • Pregnant or lactating women;
  • Patients with conditions requiring emergency surgery;
  • Tumor progress during neo-adjuvant chemotherapy
  • Severe, uncontrolled physical or metal disease.
  • Poor compliance.
  • Uncontrolled infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The sixth affliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

Related Publications (4)

  • Marutsuka T, Shimada S, Shiomori K, Hayashi N, Yagi Y, Yamane T, Ogawa M. Mechanisms of peritoneal metastasis after operation for non-serosa-invasive gastric carcinoma: an ultrarapid detection system for intraperitoneal free cancer cells and a prophylactic strategy for peritoneal metastasis. Clin Cancer Res. 2003 Feb;9(2):678-85.

    PMID: 12576435BACKGROUND

  • Lin CH, Hsieh HF, Yu JC, Chen TW, Yu CY, Hsieh CB. Peritoneal lavage with distilled water during liver resection in patients with spontaneously ruptured hepatocellular carcinomas. J Surg Oncol. 2006 Sep 1;94(3):255-6. doi: 10.1002/jso.20596.

    PMID: 16900516BACKGROUND

  • Yonemura Y, de Aretxabala X, Fujimura T, Fushida S, Katayama K, Bandou E, Sugiyama K, Kawamura T, Kinoshita K, Endou Y, Sasaki T. Intraoperative chemohyperthermic peritoneal perfusion as an adjuvant to gastric cancer: final results of a randomized controlled study. Hepatogastroenterology. 2001 Nov-Dec;48(42):1776-82.

    PMID: 11813623RESULT

  • Hamazoe R, Maeta M, Kaibara N. Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer. 1994 Apr 15;73(8):2048-52. doi: 10.1002/1097-0142(19940415)73:83.0.co;2-q.

    PMID: 8156509RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Neoadjuvant TherapyChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Jun-Sheng Peng, PhD

    The sixth affliated hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua-She Wang, PhD

CONTACT

+8613824468573angelwhs@sohu.com

Jun-Sheng Peng, PhD

CONTACT

+8613802963578pengjunsheng@tom.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

November 3, 2016

First Posted

November 9, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 9, 2016

Record last verified: 2016-10

Locations

CN(1)