NCT02672865

Brief Summary

The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in patients with locally advanced gastric cancer undergoing standard surgical resection. Patients will be treated with HIPEC using a single dose of mitomycin 15mg/m2 and cisplatin 50mg/m2 at 41-42 C for 90 minutes, during the definitive surgical resection for gastric cancer. HIPEC will be performed after resection but before anastomosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

February 2, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 2, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
Last Updated

April 12, 2019

Status Verified

April 1, 2019

Enrollment Period

2.7 years

First QC Date

February 2, 2016

Last Update Submit

April 10, 2019

Conditions

Locally Advanced Malignant NeoplasmGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Post Operative Complications

    Patients will be followed for 90 days following surgery. Postoperative complications will be recorded and graded according to the modified Clavien-Dindo classification.

    90 days following surgery

Study Arms (1)

HIPEC

EXPERIMENTAL

The administration of hyperthermic intraperitoneal chemotherapy (HIPEC), using a warm solution of two chemotherapy medications (mitomycin and cisplatin) to bathe the internal surfaces of the abdomen in an attempt to kill any microscopic cancer cells that might be present on these surfaces.

Drug: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Interventions

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)DRUG

Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the internal parts of the abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.

Also known as: HIPEC
HIPEC

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-75 with biopsy-proven gastric adenocarcinoma
  • Tumor clinically staged T3 or T4 and/or nodes staged clinically positive
  • ECOG performance status \< 2

You may not qualify if:

  • Distant metastases
  • Peritoneal carcinomatosis
  • Synchronous malignancy
  • Tumors at the gastroesophageal junction
  • Recurrent gastric adenocarcinoma
  • Creatinine \>/= 1.5
  • Bilirubin \>/= 2
  • INR \>/= 2
  • Allergy to drugs included in the treatment plan
  • Pregnancy
  • Contraindication to major surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Cancer Center

Loma Linda, California, 92354, United States

Location

Related Publications (2)

  • Seshadri RA, Glehen O. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in gastric cancer. World J Gastroenterol. 2016 Jan 21;22(3):1114-30. doi: 10.3748/wjg.v22.i3.1114.

    PMID: 26811651RESULT

  • Suo T, Mahteme H, Qin XY. Hyperthermic intraperitoneal chemotherapy for gastric and colorectal cancer in Mainland China. World J Gastroenterol. 2011 Feb 28;17(8):1071-5. doi: 10.3748/wjg.v17.i8.1071.

    PMID: 21448361RESULT

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

  • Maheswari Senthil, MD

    Loma Linda University Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 2, 2016

First Posted

February 3, 2016

Study Start

February 2, 2016

Primary Completion

October 3, 2018

Study Completion

October 3, 2018

Last Updated

April 12, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)