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Trial record 1 of 1 for:    17-C-0070
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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 : December 21, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date  ICMJE March 22, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date December 21, 2021
Actual Study Start Date  ICMJE June 5, 2017
Estimated Primary Completion Date October 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2018)
Overall survival [ Time Frame: death ]
median amount of time subject survives after therapy
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
median amount of time subject survives after therapy [ Time Frame: death ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2018)
  • intraperitoneal progression free survival [ Time Frame: at intraperitoneal progression ]
    median amount of time subject survives without intraperitoneal disease progression after treatment
  • extra-peritoneal disease free survival [ Time Frame: at extraperitoneal progression ]
    median amount of time subject survives without extraperitoneal disease progression after treatment
  • morbidity [ Time Frame: 5 years ]
    list of adverse event frequency
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • median amount of time subject survives without intraperitoneal disease progression after treatment [ Time Frame: at intraperitoneal progression ]
  • median amount of time subject survives without extraperitoneal disease progression after treatment [ Time Frame: at extraperitoneal progression ]
  • list of adverse event frequency [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
Official Title  ICMJE Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Adenocarcinoma
  • Esophagogastric Junction
  • Gastric Cancer
Intervention  ICMJE
  • Procedure: Surgery
    Heated Intraperitonial Chemotherapy (HIPEC) with gastrectomy using cisplatin, mitomycin C and sodium thiosulfate
  • Drug: Cisplatin
    Cisplatin (90 mg/m2) will be administered via circuit to the peritoneal cavity
  • Drug: Mitomycin C
    Mitomycin C 10 mg/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.
Study Arms  ICMJE Experimental: 1/Arm 1
HIPEC with gastrectomy
Interventions:
  • Procedure: Surgery
  • Drug: Cisplatin
  • Drug: Mitomycin C
  • Drug: Sodium Thiosulfate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2027
Estimated Primary Completion Date October 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
  • 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 .

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Audra A Satterwhite, R.N. (240) 858-3552 foregut@mail.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03092518
Other Study ID Numbers  ICMJE 170070
17-C-0070
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeremy L Davis, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 17, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP