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Gastric AdenocarcinomaPhase 2NCT03092518

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

A Phase 2 study testing Surgery, Cisplatin and Mitomycin C in people with Gastric Adenocarcinoma and Esophagogastric Junction, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surgery, Cisplatin and Mitomycin C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
5 Jun 2017to 24 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 25Show fewer
  • 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
  • total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST)Serum glutamic-oxaloacetic transaminase (SGOT)/Alanine aminotransferase (ALT)Serum glutamic-pyruvic transaminase (SGPT) less than or equal to 2.5 X institutional upper limit of normal
  • creatinine < 1.5 mg/dl
  • estimated glomerular filtration rate (GFR) (creatinine clearance) greater than or equal to 60 mL/min/1.73 m^2.
  • Physiologically able to undergo heated intraperitoneal chemotherapy (HIPEC) and gastrectomy
  • No history of malignancy within 2 years of enrollment except for basal cell carcinoma of the skin, squamous cell skin cancer or carcinoma in situ of the cervix.
  • Ability of subject to understand and the willingness to sign a written informed consent document
  • Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology

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).
Read more

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.
Read the 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.
Being tested
Surgery, Cisplatin, Mitomycin C, Sodium Thiosulfate, Tumor Biopsy
Keywords
Surgical Resection, Progression Free Survival, Gastroesophageal junction (Siewert III) adenocarcinoma
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

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

  • CisplatinDrug

    Also called Platinol

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

  • Mitomycin CDrug

    Also called Mitosol, Mutamycin, Jelmyto

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

  • Sodium ThiosulfateDrug

    Also called Sodium Thiosulfate Anhydrous, Sodium Hyposulfite, Sodium Thiosulfate Crystal, Prismatic Rice

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

  • Tumor BiopsyProcedure or surgery

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

  • CT C/A/PDiagnostic test

    Also called Computed Tomography of the chest, abdomen and pelvis

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

  • PET-CTDiagnostic test

    Also called Positron emission tomography - computed tomography

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

  • MRIDiagnostic test

    Also called Magnetic Resonance Imaging

    If computed tomography (CT) contraindicated.

  • EKGDiagnostic test

    Also called Electrocardiogram

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

Study groups in NCT03092518
Study groupRoleWhat they receive
Heated Intraperitoneal Chemotherapy (HIPEC) for Gastric CancerExperimentalHeated Intraperitoneal Chemotherapy (HIPEC) with gastrectomy
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

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

    Measured: 53.7 months

Secondary outcomes (3)

  1. Intraperitoneal Progression Free Survival (IPFS) at 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.

    Measured: 6 months, 12 months and 18 months

  2. Extra-peritoneal Disease-free Survival

    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).

    Measured: 48.9 months

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

    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.

    Measured: Up to 1646 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study start5 Jun 2017
  3. Primary completion5 Apr 2024
  4. Study completion24 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03092518
Sponsor's protocol ID
170070
Other IDs
17-C-0070
Status last verified
Jan 2025
First submitted
22 Mar 2017
Last updated
19 Feb 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.

Publications

  • 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.

    PubMed 12390389

  • 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.

    PubMed 20585870

  • 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.

    PubMed 24162381

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surgery, Cisplatin and Mitomycin C in people with Gastric Adenocarcinoma and Esophagogastric Junction, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 53.7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092518, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.

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