Trial Outcomes & Findings for HIPEC for Peritoneal Carcinomatosis (NCT NCT02040142)

NCT ID: NCT02040142

Last Updated: 2024-10-24

Results Overview

Completeness of cytoreduction will be estimated and recorded using a complete cytoreduction (CC) which corresponds to a residual disease (RR) score. Completeness of Cytoreduction (CC) scores range from CC0 - CC3 and correlate to residual disease as follows: CC0 = R0: No Disease, complete removal of all visible tumor with negative cytology or microscopic margin CC1 = R1: \<= 0.25 cm; complete removal of all visible tumor with positive cytology or microscopic margin CC2 = R2a: 0.25-2.5 cm; minimal residual tumor, nodule(s) ≤ 0.5 cm CC3 =R2b: \>=2.5 cm; gross residual tumor, nodule(s), \> 0.5, but ≤ 2 cm CC3 =R2c: \>=2.5 cm; extensive disease remaining, nodule(s) \> 2 cm

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Up through study discontinuation or 12 months after study treatment, whichever occurs first

Results posted on

2024-10-24

Participant Flow

Participants were recruited at 1 clinical site between early 2011 and March 2020. The first participant was enrolled into the study in November 2011.

Participant milestones

Participant milestones
Measure	HIPEC + Mitomycin C HIPEC + 40 milligrams (mg) of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. hyperthermic intraperitoneal chemotherapy (HIPEC) Mitomycin C
Overall Study STARTED	51
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Reasons for withdrawal
Measure	HIPEC + Mitomycin C HIPEC + 40 milligrams (mg) of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. hyperthermic intraperitoneal chemotherapy (HIPEC) Mitomycin C
Overall Study Lost to Follow-up	5
Overall Study Death	17
Overall Study Not Evaluable (Surgery and/or Treatment aborted but still enrolled)	14

Baseline Characteristics

HIPEC for Peritoneal Carcinomatosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIPEC + Mitomycin C n=51 Participants HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=99 Participants
Age, Categorical >=65 years	14 Participants n=99 Participants
Age, Continuous	53.4 years STANDARD_DEVIATION 13.9 • n=99 Participants
Sex: Female, Male Female	34 Participants n=99 Participants
Sex: Female, Male Male	17 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants
Race (NIH/OMB) Black or African American	21 Participants n=99 Participants
Race (NIH/OMB) White	9 Participants n=99 Participants
Race (NIH/OMB) More than one race	6 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=99 Participants
Region of Enrollment United States	51 Participants n=99 Participants

PRIMARY outcome

Timeframe: Up through study discontinuation or 12 months after study treatment, whichever occurs first

Population: Data was not collected and therefore Completeness of Cytoreduction was never able to be estimated.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 30 days following surgery

Population: 30 day Morbidity data was not collected.

Perioperative and Postoperative morbidity and mortality will be determined in patients with peritoneal carcinomatosis of colorectal, gastric, appendical, pseudomyxoma peritonei and peritoneal mesothelioma origin undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy with Mitomycin- C. The number of peri/postoperative deaths up to 30 days following the time of surgery will be recorded.

Outcome measures

Outcome measures
Measure	HIPEC + Mitomycin C n=51 Participants HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
Perioperative and Postoperative Morbidity and Mortality	2 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: For PFS, 14/51 patients were not evaluable due to either never having completed surgery, not receiving HIPEC, having no evidence of cancer at time of surgery, or death due to HIPEC and no response measurement. As such, 37 patients were evaluable for PFS.

PFS is defined as time from operation date to the first documentation of disease progression or death as a result of any cause, whichever comes first. PFS will be censored at the date of last documented progression-free status for patients who are still progression free, alive or lost to follow-up. Determination of disease progression will be based on: * Radiological (CT ± PET), and/or * Surgical (laparoscopic or open exploration) evidence of recurrent disease. Peritoneal disease progression will be confirmed by cytology or histology revealing cells morphologically consistent with malignant tumor cells

Outcome measures

Outcome measures
Measure	HIPEC + Mitomycin C n=37 Participants HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
Progression-free Survival (PFS)	11.4 months Interval 3.0 to 60.0

SECONDARY outcome

Timeframe: Up to 5 years

Population: For OS, 12/51 patients were not evaluable due to either never having completed surgery, not receiving HIPEC, or having no evidence of cancer at time of surgery. As such, 39 patients were evaluable for OS. 2 patients died within 30 days of surgery and, as such, the full range of dates was 0 months to time of last follow up prior to study termination (i.e., 60 months)

Overall survival will be calculated from the time of surgery to the time of death for any cause and will be censored at the date of last follow up visit for patients who are still alive or lost to follow up.

Outcome measures

Outcome measures
Measure	HIPEC + Mitomycin C n=39 Participants HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
Overall Survival (OS)	33.6 months Interval 0.0 to 60.0

Adverse Events

HIPEC + Mitomycin C

Serious events: 34 serious events

Other events: 50 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	HIPEC + Mitomycin C n=51 participants at risk HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
Renal and urinary disorders Acute Kidney Injury	3.9% 2/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Gastrointestinal disorders Abdominal Pain	2.0% 1/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Blood and lymphatic system disorders Febrile Neutropenia	2.0% 1/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations Aspartate Aminotransferase (AST) Increased	33.3% 17/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations Alanine Aminotransferase (ALT) Increased	27.5% 14/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations Creatinine Increased	5.9% 3/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Renal and urinary disorders Chronic Kidney Disease	5.9% 3/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.9% 2/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
General disorders Fever	7.8% 4/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Blood and lymphatic system disorders Anemia	29.4% 15/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Metabolism and nutrition disorders Hypoalbuminemia	5.9% 3/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Metabolism and nutrition disorders Hypocalcemia	43.1% 22/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Metabolism and nutrition disorders Hyperglycemia	3.9% 2/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Metabolism and nutrition disorders Hypophosphatemia	3.9% 2/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations Lymphocyte Count Decreased	35.3% 18/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Gastrointestinal disorders Intra-abdominal Hemorrhage	2.0% 1/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations Platelet Count Decreased	2.0% 1/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations White Blood Cell Decreased	21.6% 11/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations White Blood Cell Count Increased	3.9% 2/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.

Other adverse events

Other adverse events
Measure	HIPEC + Mitomycin C n=51 participants at risk HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
Investigations Aspartate Aminotransferase (AST) Increased	47.1% 24/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations Alanine Aminotransferase (ALT) Increased	43.1% 22/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Metabolism and nutrition disorders Hyperglycemia	49.0% 25/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Metabolism and nutrition disorders Hypocalcemia	58.8% 30/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Vascular disorders Hypertension	52.9% 27/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Gastrointestinal disorders Nausea	54.9% 28/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Blood and lymphatic system disorders Febrile Neutropenia	21.6% 11/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Blood and lymphatic system disorders Anemia	68.6% 35/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Metabolism and nutrition disorders Hypoalbuminemia	29.4% 15/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations Lymphocyte Count Decreased	49.0% 25/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations White Blood Cell Decreased	37.3% 19/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.
Investigations Blood Bilirubin Increased	45.1% 23/51 • Assessed throughout enrollment following the initiation of study treatment, up to 5 years Adverse events secondary to both cytoreductive surgery and the utilization of intraperitoneal chemotherapy were monitored.

Additional Information

Dr. John McAuliffe, Associate Professor Department of Surgery and Department of Pathology

Montefiore Medical Center

Phone: 718-379-6865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place