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Protocol Details

Phase II Trial of Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer with Positive Peritoneal Cytology

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-C-0070

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

Surgical Resection;
Progression Free Survival;
Gastroesophageal Junction (Siewert I-III) Adenocarcinoma

Recruitment Keyword(s)

None

Condition(s)

Gastric Adenocarcinoma;
Esophagogastric Junction;
Gastric Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Procedure/Surgery: Surgery
Drug: Cisplatin
Drug: Mitomycin C
Drug: Sodium Thiosulfate

Supporting Site

National Cancer Institute

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.

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Eligibility

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.


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Citations:

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.

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.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Jeremy L. Davis, M.D.
National Cancer Institute (NCI)



Audra A. Satterwhite, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 4W5920
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3552
foregut@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03092518

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