- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02891447
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer
A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration.
SECONDARY OBJECTIVES:
I. To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.
OUTLINE:
Patients undergo hyperthermic intraperitoneal chemotherapy (HIPEC) comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
After completion of study treatment, patients are followed up within 4 weeks, and then every 6 months for 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 60,000/Ul
- Serum creatinine =< 1.5 mg/dL
Distant metastatic disease of peritoneum may be visualized on imaging:
- Positive peritoneal cytology
- Carcinomatosis on diagnostic laparoscopy or laparotomy
- Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC
Exclusion Criteria:
- Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, lung)
- Infections such as pneumonia or wound infections that would preclude protocol therapy
- Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
- Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
- Subjects deemed unable to comply with study and/or follow-up procedures
- Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (mitomycin, cisplatin)
Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
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Undergo HIPEC
Other Names:
Given intraperitoneally
Other Names:
Given intraperitoneally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: From the time of diagnosis of stage IV disease up to 5 years
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Overall survival time will be estimated using the Kaplan-Meier method.
The two-sided log-rank test will be used to assess the differences of time to events between groups.
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From the time of diagnosis of stage IV disease up to 5 years
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Patterns of tumor recurrence
Time Frame: Up to 5 years
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Will be assessed by reviewing routine surveillance imaging.
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: From the time of surgery up to 5 years
|
Overall survival time will be estimated using the Kaplan-Meier method.
The two-sided log-rank test will be used to assess the differences of time to events between groups.
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From the time of surgery up to 5 years
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Digestive System Neoplasms
- Abdominal Neoplasms
- Carcinoma
- Adenocarcinoma
- Peritoneal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Alkylating Agents
- Antibiotics, Antineoplastic
- Cisplatin
- Mitomycins
- Mitomycin
Other Study ID Numbers
- 2016-0269 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2018-02341 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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