Heated Intraperitoneal Chemotherapy and Gastrectomy for Gastric Cancer With Positive Peritoneal Cytology
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| ClinicalTrials.gov Identifier: NCT03092518 |
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Recruitment Status :
Recruiting
First Posted : March 28, 2017
Last Update Posted : February 3, 2023
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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 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| 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, 2025 |
| Estimated Study Completion Date : | October 1, 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1/Arm 1
HIPEC with gastrectomy
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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. |
- Overall survival [ Time Frame: death ]median amount of time subject survives after therapy
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- 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
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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.
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
| Contact: Cathleen E Hannah | (240) 409-8860 | foregut@mail.nih.gov | |
| Contact: Jeremy L Davis, M.D. | (240) 858-3731 | jeremy.davis@nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 ccopr@nih.gov | |
| Principal Investigator: | Jeremy L Davis, M.D. | National Cancer Institute (NCI) |
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT03092518 |
| Other Study ID Numbers: |
170070 17-C-0070 |
| First Posted: | March 28, 2017 Key Record Dates |
| Last Update Posted: | February 3, 2023 |
| Last Verified: | January 30, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | .All IPD recorded in the medical record will be shared with intramural investigators upon request. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) |
| Time Frame: | Clinical data available during the study and indefinitely. |
| Access Criteria: | Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Surgical Resection Progression Free Survival Gastroesophageal junction (Siewert III) adenocarcinoma |
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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 |