Trial Outcomes & Findings for Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer (NCT NCT02092298)

NCT ID: NCT02092298

Last Updated: 2021-06-15

Results Overview

Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after laparoscopic hyperthermic intraperitoneal chemotherapy administration. Overall survival measured from time of laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Between the second and sixth week after treatment, up to 5 years

Results posted on

2021-06-15

Participant Flow

Recruitment Period: May 2014-July 2016. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

A total of 21 participants were consented, 2 participants were screen failures

Participant milestones

Participant milestones
Measure	Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours. Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes. Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy. Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyperthermic Intraperitoneal Chemotherapy (HIPEC) n=19 Participants Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours. Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes. Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy. Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.
Age, Continuous	51 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Between the second and sixth week after treatment, up to 5 years

Outcome measures

Outcome measures
Measure	Hyperthermic Intraperitoneal Chemotherapy (HIPEC) n=19 Participants Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours. Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes. Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy. Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.
Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy	30.2 Months Standard Deviation 18.3

PRIMARY outcome

Timeframe: From the day of surgery, until the last day of follow up, until death, up to 5 years

Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after the first laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Hyperthermic Intraperitoneal Chemotherapy (HIPEC) n=19 Participants Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours. Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes. Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy. Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.
Overall Survival (OS) From the First Laparoscopic HIPEC	20.3 Months Standard Deviation 7.2

Adverse Events

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 18 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hyperthermic Intraperitoneal Chemotherapy (HIPEC) n=19 participants at risk Laparoscopic HIPEC consists of Mitomycin C 30 mg and Cisplatin 200 mg for 60 minutes, performed 2-8 weeks after completion of systemic chemotherapy. Loading dose Sodium Thiosulfate 7.5 gm/M2 infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by infusion pump over 12 hours. Mitomycin C: Mitomycin C 30 mg delivered laparoscopically for 60 minutes. Cisplatin: Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy. Sodium Thiosulfate: Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.
Cardiac disorders Arrythmia	5.3% 1/19 • Serious and Other (Not Including Serious Adverse Events) for 30 days and All-Cause Mortality for 5 years
Renal and urinary disorders Kidney dysfunction	5.3% 1/19 • Serious and Other (Not Including Serious Adverse Events) for 30 days and All-Cause Mortality for 5 years
Respiratory, thoracic and mediastinal disorders Lung Injury	5.3% 1/19 • Serious and Other (Not Including Serious Adverse Events) for 30 days and All-Cause Mortality for 5 years
Blood and lymphatic system disorders Blood Clot	5.3% 1/19 • Serious and Other (Not Including Serious Adverse Events) for 30 days and All-Cause Mortality for 5 years

Additional Information

Brian Badgwell,Professor, Surgical Oncology

UT MD Anderson Cancer Center

Phone: 713-745-3715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place