Phase 2
N=19
Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer
Gastrointestinal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02092298 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy — 30.2 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mitomycin C (Drug); Cisplatin (Drug); Sodium Thiosulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy |
30.2 | — |
| PRIMARY Overall Survival (OS) From the First Laparoscopic HIPEC |
20.3 | — |
Summary
The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or gastroesophageal cancer. The safety of this treatment will also be studied.
Eligibility Criteria
Inclusion Criteria
- Age 18 years and above. There will be no upper age restriction.
- Eastern Cooperative Oncology Group (ECOG) performance status /= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine </= 1.5 mg/dL.
- Hepatic function: AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN.
- Distant Metastatic Disease limited to peritoneum and radiologically occult (not visualized on preoperative imaging to include [Computerized Tomography] CT scan, Ultrasound, [Magnetic Resonance Imaging] MRI, PET/CT): a. Positive peritoneal cytology; b. Carcinomatosis on diagnostic laparoscopy or laparotomy.
- Completion of preoperative systemic chemotherapy.
Exclusion Criteria
- Distant metastatic disease not limited to peritoneum: a. Solid organ metastases (liver, central nervous system, lung).
- Any distant metastatic disease visualized on preoperative imaging: a. Solid organ metastases; b. Clear radiologic evidence of carcinomatosis.
- 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.
Data sourced from ClinicalTrials.gov (NCT02092298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.