Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

Gastric Adenocarcinoma Clinical Trial

Official title:

A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891447
• Other study ID #: 2016-0269
• Secondary ID: NCI-2018-0234120
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2016
• Est. completion date: April 11, 2023

Study information

• Verified date: April 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 11, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Drug:
• Cisplatin
Given intraperitoneally
• Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
• Mitomycin
Given intraperitoneally

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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.	From the time of diagnosis of stage IV disease up to 5 years
Primary	Patterns of tumor recurrence	Will be assessed by reviewing routine surveillance imaging.	Up to 5 years
Secondary	Overall survival	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.	From the time of surgery up to 5 years

External Links

•   MD Anderson Cancer Center Website