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

Phase 2

Completed

Conditions: Esophagogastric Junction
Gastric Cancer
Gastric Adenocarcinoma

Interventions: Procedure: Surgery
Drug: Cisplatin
Drug: Mitomycin C
Drug: Sodium Thiosulfate
Procedure: Tumor Biopsy
Diagnostic Test: CT C/A/P
Diagnostic Test: PET-CT
Diagnostic Test: MRI
Diagnostic Test: EKG

Registration Number: NCT03092518

Lead Sponsor: National Cancer Institute (NCI)

Brief Summary: Background:

- Gastric cancer is a common and serious cancer. Standard treatment is chemotherapy drugs. Researchers want to see if a new treatment helps. It is surgical removal of the cancer and heated chemotherapy delivered to the abdominal cavity called Hyperthermic intraperitoneal chemotherapy (HIPEC).

Objective:

- To test if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve survival in people with gastric cancers.

Eligibility:

- People ages 18 and older with gastric cancer who can have most tumors surgically removed

Design:

* Participants will be screened with:

* Medical history

* Physical exam

* Blood, urine, and heart tests

* Scans

* Tissue sample from previous surgery

* Endoscopy with biopsy: A tube with a camera goes through the mouth and into the stomach. It and takes a sample of stomach tissue. Participants may get medicine to make them drowsy.

* Laparoscopy: Small cuts are made in the abdomen. A thin tube with a light and camera is inserted into the abdomen. Participants sleep through the procedure.

Participants will stay in the hospital. They will have:

* Surgery to remove as many tumors as possible.

* HIPEC for 60 minutes: Two thin tubes are put into the abdomen. Two chemotherapy drugs are given through one tube. They are drained out through another at a temperature a few degrees above normal body temperature. Another drug is given in a vein.

* Recovery for 7-21 days: Participants will have tubes in their stomach and bladder and intravenous (IVs) for a few days. They will get pain medicine, IV fluids, antibiotics, and blood transfusions as needed.

* Participants will have visits every few months for 3 years, then one a year. Visits include physical exam, blood tests, and scans. They also include dietary assessment and questions.

Detailed Description: Background:

* An estimated 24,590 cases of gastric adenocarcinoma are diagnosed annually in the United States (U.S.).

* The peritoneal surface is a site of metastasis found often at time of diagnosis and is a common (40%) site of recurrence.

* Laparoscopy with peritoneal lavage and cytopathologic analysis is a staging modality that can identify a subset of patients with microscopic peritoneal metastasis prior to consideration for definitive surgical therapy.

* Intraperitoneal chemotherapy has been employed in advanced gastric cancers and as an adjuvant with an associated improvement in survival in systematic reviews.

Objectives:

- Determine the overall survival in patients with cytology-positive gastric cancer treated with Hyperthermic intraperitoneal chemotherapy (HIPEC) and gastrectomy.

Eligibility:

* Histologically confirmed adenocarcinoma of the stomach.

* Cytopathologic evidence of peritoneal carcinomatosis.

* Medically fit for systemic chemotherapy, HIPEC and gastrectomy.

Design:

- Single arm, Phase II study of HIPEC and gastrectomy.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	Surgery	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	Mitomycin C	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	CT C/A/P	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	Cisplatin	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	Tumor Biopsy	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	Sodium Thiosulfate	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	PET-CT	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	MRI	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer	EKG	Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	53.7 months	OS is defined as the median amount of time a participant survives after therapy.

Secondary Outcome Measures

Name	Time	Method
Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months	6 months, 12 months and 18 months	Intraperitoneal progression free survival is defined as the median amount of time a participant survives from date of operation (hyperthermic intraperitoneal chemotherapy (HIPEC) and gastrectomy) without intraperitoneal disease progression after treatment. Intraperitoneal progression is defined as new, large volume ascites with or without associated peritoneal nodularity or thickening determined by radiographic imaging, cytopathology or histopathology.
Extra-peritoneal Disease-free Survival	48.9 months	Extra-peritoneal disease-free survival is defined as the median amount of time a participant survives from date of surgery to the date of first observation of progressive disease at sites other than the peritoneal surface (e.g., liver, intra-abdominal lymph nodes, abdominal wall soft tissues, and any other solid organs) determined by radiographic imaging (i.e., computed tomography, magnetic resonance imaging, and/or positron emission tomography).
Number of Treatment Related Serious and/or Non-serious Adverse Events by Type	Up to 1646 days	The number of treatment related serious and/or non-serious adverse events by type related to research treatments was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.