Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

June 5, 2017

Primary Completion Date

April 5, 2024

Study Completion Date

July 24, 2024

Conditions
Gastric AdenocarcinomaEsophagogastric JunctionGastric Cancer
Interventions
PROCEDURE

Surgery

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate

DRUG

Cisplatin

Cisplatin (90 mg/m\^2) will be administered via circuit to the peritoneal cavity

DRUG

Mitomycin C

Mitomycin C 10 mg/m\^2 will be administered via circuit to the peritoneal cavity

DRUG

Sodium Thiosulfate

Sodium thiosulfate will be administered by continuous intravenous infusion starting immediately prior to the chemotherapy perfusion and continuing for a total of 12 hours.

PROCEDURE

Tumor Biopsy

At screening, baseline (if not done at screening) and operation (as clinically indicated).

DIAGNOSTIC_TEST

CT C/A/P

At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up.

DIAGNOSTIC_TEST

PET-CT

At screening, baseline (if not done at screening), post op care, post-discharge visits/follow-up, semi-annual follow-up and annual follow-up.

DIAGNOSTIC_TEST

MRI

If computed tomography (CT) contraindicated.

DIAGNOSTIC_TEST

EKG

At screening and baseline (if not done at screening).

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT03092518 - Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology | Biotech Hunter | Biotech Hunter