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

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ClinicalTrials.gov Identifier: NCT03092518
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( 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 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 might 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 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.


Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Esophagogastric Junction Gastric Cancer Procedure: Surgery Drug: Cisplatin Drug: Mitomycin C Drug: Sodium Thiosulfate Phase 2

Detailed Description:

Background:

  • An estimated 24,590 cases of gastric adenocarcinoma are diagnosed annually in the 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 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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: 1/Arm 1
HIPEC with gastrectomy
Procedure: Surgery
Heated Intraperitonial Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitocycin C and sodium thiosulfate

Drug: Cisplatin
Cisplatin (90mg/m2) will be administered via circuit to the peritoneal cavity.

Drug: Mitomycin C
Mytomycin C 10mg/m2 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.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: death ]
    median amount of time subject survives after therapy


Secondary Outcome Measures :
  1. intraperitoneal progression free survival [ Time Frame: at intraperitoneal progression ]
    median amount of time subject survives without intraperitoneal disease progression after treatment

  2. extra-peritoneal disease free survival [ Time Frame: at extraperitoneal progression ]
    median amount of time subject survives without extraperitoneal disease progression after treatment

  3. morbidity [ Time Frame: 5 years ]
    list of adverse event frequency



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Patients must have histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction (Siewert I-III) adenocarcinoma confirmed by the Laboratory of Pathology, 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 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.
  • 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

AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal

creatinine < 1.5 mg/dl

eGFR (creatinine clearance) greater than or equal to 60 mL/min/1.73 m2.

  • Physiologically able to undergo 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

EXCLUSION CRITERIA:

  • 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 infants secondary to treatment of the mother with HIPEC and gastrectomy, breastfeeding should be discontinued if the mother is treated on this study.
  • HIV-positive patients may be considered for this study only after consultation with a NIAID physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092518


Contacts
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Contact: NIH Foregut Team (240) 858-3610 foregut@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jeremy L Davis, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03092518     History of Changes
Other Study ID Numbers: 170070
17-C-0070
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: September 26, 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Surgical Resection
Progression Free Survival
Gastroesophageal Junction (Siewert III) Adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Sodium thiosulfate
Cisplatin
Mitomycins
Mitomycin
Antineoplastic Agents
Antibiotics, Antineoplastic
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents