Trial Outcomes & Findings for Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy Plus Systemic Therapy Versus Systemic Therapy Alone: GYMSSA Trial (NCT NCT00941655)

NCT ID: NCT00941655

Last Updated: 2019-11-13

Results Overview

Time between the first day of treatment and the date of death.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

15 participants

Primary outcome timeframe

12 weeks up to 3 years

Results posted on

2019-11-13

Participant Flow

Participant milestones

Participant milestones
Measure	Surgery + HIPEC + Systemic Chemotherapy Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Overall Study STARTED	8	7
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgery + HIPEC + Systemic Chemotherapy Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Overall Study received some chemo, 4 and 9 cycles	1	0
Overall Study not meet criteria for chemo foll surgery	4	0
Overall Study progressed while on chemo	0	2
Overall Study refused further treatment	0	1
Overall Study withdrew consent	0	1
Overall Study non-compliant	0	1

Baseline Characteristics

Prospective Randomized Trial Comparing Gastrectomy, Metastasectomy Plus Systemic Therapy Versus Systemic Therapy Alone: GYMSSA Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone n=7 Participants Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Total n=15 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	45.73 years STANDARD_DEVIATION 14.88 • n=5 Participants	52.94 years STANDARD_DEVIATION 11.67 • n=7 Participants	49.33 years STANDARD_DEVIATION 13.44 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks up to 3 years

Population: Patient #7 - alive 14 months at time of study closure; patient 11 alive 12 months at time of study closure; patient 15 expired following surgery.

Time between the first day of treatment and the date of death.

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I Patient #1	19 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I Patient #2	11 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I Patient #4	11 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I Patient #6	4 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I Patient #7	14 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I Patient #9	5 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I Patient #11	12 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I Patient #15	0 Months	—

PRIMARY outcome

Timeframe: 12 weeks up to 3 years

Population: Patient #3 - alive 17 months at time of study closure; patient 5 alive 6 months at time of study closure; patient 13 alive 8 months at time of study closure; patients 10,12 randomized but withdrew/no treatment; patient 14 randomized but did not return for treatment and lost to follow up. Patient #16 was lost to follow up after being randomized.

Time between the first day of treatment and the date of death

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=7 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II Patient #3	17 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II Patient #5	6 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II Patient #8	10 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II Patient #10	0 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II Patient #12	0 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II Patient #13	8 Months	—
Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II Patient #14	0 Months	—

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately, 40.5 months

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone n=7 Participants Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Number of Participants With Serious and Non-Serious Adverse Events	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 12 months

Participants who were alive and disease free at 12 months. DFS was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was disappearance of all target lesions. Partial response was at least a 30% decrease in target lesions. Progression was at least a 20% increase in target lesions and stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone n=7 Participants Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
12 Months Disease Free Survival (DFS)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1

Gillys stage measures the completeness of the cytoreduction and is recorded before and after surgery. It is used to classify disease burden and determine prognosis. Stage 0 is no macroscopic signs of disease, stage 1 is nodules \>5mm in one part of the abdomen, stage 2 is nodules \>5 mm throughout the abdomen, stage 3 is nodules 5mm to 2 cm, and stage 4 is nodules \< 2 cm.

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Gillys Stage Before and After Surgery Patient 1 Before Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 1 After Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 2 Before Surgery	1 Stage	—
Gillys Stage Before and After Surgery Patient 2 After Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 3 Before Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 3 After Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 4 Before Surgery	3 Stage	—
Gillys Stage Before and After Surgery Patient 4 After Surgery	1 Stage	—
Gillys Stage Before and After Surgery Patient 5 Before Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 5 After Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 6 Before Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 6 After Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 7 Before Surgery	1 Stage	—
Gillys Stage Before and After Surgery Patient 7 After Surgery	0 Stage	—
Gillys Stage Before and After Surgery Patient 8 Before Surgery	3 Stage	—
Gillys Stage Before and After Surgery Paitent 8 After Surgery	0 Stage	—

SECONDARY outcome

Timeframe: Day 1

CCR is assessed by Sugarbaker's criteria. CCR-0 is no residual tumor. CCR-1 is no residual nodules greater than 2.5 mm in diameter, CCR-2 is no residual nodules greater than 25 mm, and CCR-3 is residual nodules greater than 25 mm.

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Completeness of Cytoreduction (CCR) Score Patient 1	0 Scores on a scale	—
Completeness of Cytoreduction (CCR) Score Patient 2	0 Scores on a scale	—
Completeness of Cytoreduction (CCR) Score Patient 3	0 Scores on a scale	—
Completeness of Cytoreduction (CCR) Score Patient 4	2 Scores on a scale	—
Completeness of Cytoreduction (CCR) Score Patient 5	0 Scores on a scale	—
Completeness of Cytoreduction (CCR) Score Patient 6	0 Scores on a scale	—
Completeness of Cytoreduction (CCR) Score Patient 7	0 Scores on a scale	—
Completeness of Cytoreduction (CCR) Score Patient 8	0 Scores on a scale	—

SECONDARY outcome

Timeframe: Day 1

Blood loss during surgery is related to complexity of the operation and via that to the stage of disease (more tumor to be cytoreduced, more blood loss).

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Median Blood Loss During Surgery	650 ml Interval 400.0 to	—

SECONDARY outcome

Timeframe: 1-10 weeks

Recuperation period following complex surgery for this disease.

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Median Hospital Stay After Initial Surgery	17 Days Interval 7.0 to 42.0	—

SECONDARY outcome

Timeframe: up to 12 hours

Time it takes to perform this complex surgery and HIPEC to reduce tumor burden overall in this disease.

Outcome measures

Outcome measures
Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 Participants Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy (HIPEC) with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Median Duration of Cytoreduction Surgery and Heated Intraperitoneal Chemotherapy (HIPEC)	10.1 hours Interval 5.0 to 12.0	—

SECONDARY outcome

Timeframe: up to 3 years

Population: Zero participants were analyzed because data collected was insufficient due to the small sample size (I.e. too few patients to analyze) to make any comparisons that might be interpretable and subject to statistical rigor. Outcome will not be explored further.

QOL tools Functional Assessment of Cancer Therapy - Gastric cancer (FACT-Ga) specifically developed for the assessment of QOL in gastric cancer patients.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 years

Compare surgery + heated intraperitoneal chemotherapy + systemic chemotherapy; and systemic chemotherapy alone to determine how each group responds clinically.

Outcome measures

Outcome data not reported

Adverse Events

Surgery + HIPEC + Systemic Chemotherapy

Serious events: 8 serious events

Other events: 8 other events

Deaths: 7 deaths

Systemic Chemotherapy Alone

Serious events: 1 serious events

Other events: 5 other events

Deaths: 7 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Udo Rudloff

National Cancer Institute, National Institutes of Health

Phone: 301-496-3098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 participants at risk Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone n=7 participants at risk Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Colitis	12.5% 1/8 • Number of events 3 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Metabolism and nutrition disorders Creatinine	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Dehydration	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
General disorders Fatigue (asthenia, lethargy, malaise)	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Infections and infestations Febrile neutropenia	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Blood and lymphatic system disorders Hemoglobin	50.0% 4/8 • Number of events 4 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Hemorrhage, GI:Peritoneal cavity	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Infections and infestations Infection: Infection (documented clinically or microbiologically)	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Infections and infestations Infection: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Infections and infestations Infection with unknown ANC: Wound	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Leak (including anastomotic), GI: Esophagus	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Leak (including anastomotic), GI: Pancreas	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Malabsorption	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Obstruction, GI:Small bowel NOS	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Blood and lymphatic system disorders PTT (partial thromboplastin time)	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Pain:Abdomen NOS	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Perforation, GI:Esophagus	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Blood and lymphatic system disorders Platelets	37.5% 3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Vascular disorders Thrombosis/thrombus/embolism	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
General disorders Weight loss	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Renal and urinary disorders Obstruction, GU:Ureter	0.00% 0/8 • Date treatment consent signed to date off study, approximately, 40.5 months.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.

Measure	Surgery + HIPEC + Systemic Chemotherapy n=8 participants at risk Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m\^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m\^2 IV and Oxaliplatin 460 mg/m\^2 diluted in 2.0 L/m\^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion. Systemic chemotherapy - Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.	Systemic Chemotherapy Alone n=7 participants at risk Irinotecan 165 mg/m\^2 IV over 90 minutes, Oxaliplatin 85 mg/m\^2 over 120 minutes, Leucovorin 200 mg/m\^2 IV 120 minutes, 5FU 3200 mg/m\^2 continuous IV infusion over 48 hours.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Metabolism and nutrition disorders AST, SGOT (serum glutamic oxaloacetic transaminase)	75.0% 6/8 • Number of events 6 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Metabolism and nutrition disorders CPK (creatine phosphokinase)	50.0% 4/8 • Number of events 4 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Dehydration	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Diarrhea	0.00% 0/8 • Date treatment consent signed to date off study, approximately, 40.5 months.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Distention, bloating, abdominal	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Blood and lymphatic system disorders Edema: limb	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
General disorders Fatigue (asthenia, lethargy, malaise)	0.00% 0/8 • Date treatment consent signed to date off study, approximately, 40.5 months.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	0.00% 0/8 • Date treatment consent signed to date off study, approximately, 40.5 months.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.
Blood and lymphatic system disorders Hemoglobin	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.
Infections and infestations Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: Upper airway NOS	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Infections and infestations Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: Urinary tract NOS	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Nausea	25.0% 2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately, 40.5 months.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.
Nervous system disorders Neurology - Other (Specify, tingling hands/feet)	0.00% 0/8 • Date treatment consent signed to date off study, approximately, 40.5 months.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.
Nervous system disorders Neuropathy: sensory	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	28.6% 2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	50.0% 4/8 • Number of events 5 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Pain:Abdomen NOS	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.
Metabolism and nutrition disorders Phosphate, serum-low (hypophospatemia)	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Blood and lymphatic system disorders Platelets	12.5% 1/8 • Number of events 7 • Date treatment consent signed to date off study, approximately, 40.5 months.	14.3% 1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Cardiac disorders Supraventricular and nodal arrhythmia - Atrial fibrillation	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately, 40.5 months.	14.3% 1/7 • Number of events 11 • Date treatment consent signed to date off study, approximately, 40.5 months.
General disorders Weight loss	25.0% 2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately, 40.5 months.	0.00% 0/7 • Date treatment consent signed to date off study, approximately, 40.5 months.