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

NCT03092518 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 17007017-C-0070
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Adenocarcinoma; Esophagogastric Junction; Gastric Cancer

Keywords

Surgical Resection; Progression Free Survival; Gastroesophageal junction (Siewert III) adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as the median amount of time a participant survives after therapy.

  53.7 months

Secondary Outcomes (3)

• Intraperitoneal Progression Free Survival (IPFS) at 6 Months, 12 Months and 18 Months

  6 months, 12 months and 18 months

• Extra-peritoneal Disease-free Survival

  48.9 months

• Number of Treatment Related Serious and/or Non-serious Adverse Events by Type

  Up to 1646 days

Other Outcomes (1)

• Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

  Document adverse events from the first study intervention (pre-operation visit) through 30 days after removal from study treatment or until off-study, whichever comes first, approximately 365 days

Study Arms (1)

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

EXPERIMENTAL

Heated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy

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

Interventions

Surgery PROCEDURE

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

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Cisplatin DRUG

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

Also known as: Platinol

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Mitomycin C DRUG

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

Also known as: Mitosol, Mutamycin, Jelmyto

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Sodium Thiosulfate DRUG

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

Also known as: Sodium Thiosulfate Anhydrous, Sodium Hyposulfite, Sodium Thiosulfate Crystal, Prismatic Rice

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Tumor Biopsy PROCEDURE

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

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

CT C/A/P DIAGNOSTIC_TEST

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

Also known as: Computed Tomography of the chest, abdomen and pelvis

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

PET-CT DIAGNOSTIC_TEST

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

Also known as: Positron emission tomography - computed tomography

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

MRI DIAGNOSTIC_TEST

If computed tomography (CT) contraindicated.

Also known as: Magnetic Resonance Imaging

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

EKG DIAGNOSTIC_TEST

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

Also known as: Electrocardiogram

Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert I-III) adenocarcinoma confirmed by the Laboratory of Pathology, national Cancer Institute (NCI).
• Must have received systemic chemotherapy, minimum 3 months or maximum 6 months, prior to enrollment
• Systemic therapy should consist of at least fluoropyrimidine-based and/or platinum-based chemotherapy
• Trastuzumab may be added for human epidermal growth factor receptor 2 (HER2)-neu over-expressing cancers as clinically indicated
• Last dose of chemotherapy within 8 weeks of enrollment with recovery to Grade 1 from chemotherapy-related toxicities
• Documentation of chemotherapy administration must be obtained
• Subradiographic and/or cytopathologic evidence of peritoneal carcinomatosis found at staging laparoscopy.
• Documentation of cytopathologic diagnosis of malignant peritoneal cytology in the absence of disseminated peritoneal disease must be obtained. If cytologic analysis reveals atypical cells of undetermined significance, a repeat lavage with cytopathologic analysis will be performed and must demonstrate evidence of malignancy.
• Limited peritoneal involvement found at staging laparoscopy or on final pathology that is deemed completely resectable is permitted
• Age \>18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status \<2
• Patients must have normal organ and marrow function as defined below:
• hemoglobin \> 8.0 g/dL
• absolute neutrophil count greater than or equal to 1,000/mcL
• platelets greater than or equal to100,000/mcL

You may not qualify if:

• Patients who are receiving any investigational agents
• Disseminated extra-peritoneal or solid organ metastases
• Includes carcinomatosis associated with clinically or radiographically evident ascites (greater than 500cc)
• Excludes greater omentum and ovarian metastases
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study because HIPEC and gastrectomy have not been studied in pregnant women and has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infant's secondary to treatment of the mother with HIPEC and gastrectomy, breastfeeding should be discontinued if the mother is treated on this study.
• Human immunodeficiency virus (HIV)-positive patients may be considered for this study only after consultation with a National Institute of Allergy and Infectious Diseases (NIAID) physician.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Hartgrink HH, Putter H, Klein Kranenbarg E, Bonenkamp JJ, van de Velde CJ; Dutch Gastric Cancer Group. Value of palliative resection in gastric cancer. Br J Surg. 2002 Nov;89(11):1438-43. doi: 10.1046/j.1365-2168.2002.02220.x.

  PMID: 12390389 BACKGROUND

• Mezhir JJ, Shah MA, Jacks LM, Brennan MF, Coit DG, Strong VE. Positive peritoneal cytology in patients with gastric cancer: natural history and outcome of 291 patients. Ann Surg Oncol. 2010 Dec;17(12):3173-80. doi: 10.1245/s10434-010-1183-0. Epub 2010 Jun 29.

  PMID: 20585870 BACKGROUND

• Kang YK, Yook JH, Chang HM, Ryu MH, Yoo C, Zang DY, Lee JL, Kim TW, Yang DH, Jang SJ, Park YS, Lee YJ, Jung HY, Kim JH, Kim BS. Enhanced efficacy of postoperative adjuvant chemotherapy in advanced gastric cancer: results from a phase 3 randomized trial (AMC0101). Cancer Chemother Pharmacol. 2014 Jan;73(1):139-49. doi: 10.1007/s00280-013-2332-5. Epub 2013 Oct 27.

  PMID: 24162381 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma

Interventions

Surgical Procedures, Operative; Cisplatin; Mitomycin; sodium thiosulfate; Positron Emission Tomography Computed Tomography; Magnetic Resonance Imaging; Electrocardiography

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Results Point of Contact

• Title: Dr. Jeremy Davis
• Organization: National Cancer Institute

jeremy.davis@nih.gov

2408583731

Study Officials

• Jeremy L Davis, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: June 5, 2017
• Primary Completion: April 5, 2024
• Study Completion: July 24, 2024
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to the Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).

Locations

US (1)