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

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ClinicalTrials.gov Identifier: NCT00941655
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : July 11, 2013
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Udo Rudloff, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastric Cancer
Interventions Drug: Oxaliplatin
Drug: Irinotecan
Drug: 5-Fluorouracil
Drug: Leucovorin
Procedure: Gastrectomy and/or metastasectomy
Enrollment 15

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
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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.

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.
Period Title: Overall Study
Started 8 7
Completed 3 2
Not Completed 5 5
Reason Not Completed
received some chemo, 4 and 9 cycles             1             0
not meet criteria for chemo foll surgery             4             0
progressed while on chemo             0             2
refused further treatment             0             1
withdrew consent             0             1
non-compliant             0             1
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone Total
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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.

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 of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
6
  85.7%
14
  93.3%
>=65 years
0
   0.0%
1
  14.3%
1
   6.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 15 participants
45.73  (14.88) 52.94  (11.67) 49.33  (13.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female
2
  25.0%
4
  57.1%
6
  40.0%
Male
6
  75.0%
3
  42.9%
9
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Hispanic or Latino
5
  62.5%
0
   0.0%
5
  33.3%
Not Hispanic or Latino
3
  37.5%
7
 100.0%
10
  66.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  14.3%
1
   6.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
7
  87.5%
6
  85.7%
13
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  12.5%
0
   0.0%
1
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 7 participants 15 participants
8 7 16
1.Primary Outcome
Title Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm I
Hide Description Time between the first day of treatment and the date of death.
Time Frame 12 weeks up to 3 years
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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.
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Months
Patient #1 19
Patient #2 11
Patient #4 11
Patient #6 4
Patient #7 14
Patient #9 5
Patient #11 12
Patient #15 0
2.Primary Outcome
Title Overall Survival in Patients With Limited Metastatic Gastric Carcinoma: Arm II
Hide Description Time between the first day of treatment and the date of death
Time Frame 12 weeks up to 3 years
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Hide Analysis Population Description
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.
Arm/Group Title Systemic Chemotherapy Alone
Hide Arm/Group Description:
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 Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Months
Patient #3 17
Patient #5 6
Patient #8 10
Patient #10 0
Patient #12 0
Patient #13 8
Patient #14 0
3.Secondary Outcome
Title Count of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 40.5 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
5
  71.4%
4.Secondary Outcome
Title 12 Months Disease Free Survival (DFS)
Hide Description 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.
Time Frame 12 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  25.0%
0
   0.0%
5.Secondary Outcome
Title Gillys Stage Before and After Surgery
Hide Description 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.
Time Frame Day 1
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Stage
Patient 1 Before Surgery 0
Patient 1 After Surgery 0
Patient 2 Before Surgery 1
Patient 2 After Surgery 0
Patient 3 Before Surgery 0
Patient 3 After Surgery 0
Patient 4 Before Surgery 3
Patient 4 After Surgery 1
Patient 5 Before Surgery 0
Patient 5 After Surgery 0
Patient 6 Before Surgery 0
Patient 6 After Surgery 0
Patient 7 Before Surgery 1
Patient 7 After Surgery 0
Patient 8 Before Surgery 3
Paitent 8 After Surgery 0
6.Secondary Outcome
Title Completeness of Cytoreduction (CCR) Score
Hide Description 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.
Time Frame Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: Scores on a scale
Patient 1 0
Patient 2 0
Patient 3 0
Patient 4 2
Patient 5 0
Patient 6 0
Patient 7 0
Patient 8 0
7.Secondary Outcome
Title Median Blood Loss During Surgery
Hide Description 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).
Time Frame Day 1
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: ml
650
(400 to 2,800)
8.Secondary Outcome
Title Median Hospital Stay After Initial Surgery
Hide Description Recuperation period following complex surgery for this disease.
Time Frame 1-10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: Days
17
(7 to 42)
9.Secondary Outcome
Title Median Duration of Cytoreduction Surgery and Heated Intraperitoneal Chemotherapy (HIPEC)
Hide Description Time it takes to perform this complex surgery and HIPEC to reduce tumor burden overall in this disease.
Time Frame up to 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: hours
10.1
(5 to 12)
10.Secondary Outcome
Title Quality of Life (QOL) Parameters Between the Two Study Groups
Hide Description QOL tools Functional Assessment of Cancer Therapy - Gastric cancer (FACT-Ga) specifically developed for the assessment of QOL in gastric cancer patients.
Time Frame up to 3 years
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Hide Analysis Population Description
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.
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Patterns of Disease Recurrence Between the Two Therapeutic Approaches and Their Clinical Implications
Hide Description Compare surgery + heated intraperitoneal chemotherapy + systemic chemotherapy; and systemic chemotherapy alone to determine how each group responds clinically.
Time Frame up to 3 years
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Hide Analysis Population Description
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.
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 40.5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
Hide Arm/Group Description

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.

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.
All-Cause Mortality
Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   7/8 (87.50%)      7/7 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      1/7 (14.29%)    
Blood and lymphatic system disorders     
Hemoglobin  1  4/8 (50.00%)  4 0/7 (0.00%)  0
Neutrophils/granulocytes (ANC/AGC)  1  2/8 (25.00%)  2 0/7 (0.00%)  0
PTT (partial thromboplastin time)  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Platelets  1  3/8 (37.50%)  3 0/7 (0.00%)  0
Gastrointestinal disorders     
Colitis  1  1/8 (12.50%)  3 0/7 (0.00%)  0
Dehydration  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Hemorrhage, GI:Peritoneal cavity  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Leak (including anastomotic), GI: Esophagus  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Leak (including anastomotic), GI: Pancreas  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Malabsorption  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Nausea  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Obstruction, GI:Small bowel NOS  1  2/8 (25.00%)  2 0/7 (0.00%)  0
Pain:Abdomen NOS  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Perforation, GI:Esophagus  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Vomiting  1  1/8 (12.50%)  1 0/7 (0.00%)  0
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  2/8 (25.00%)  2 0/7 (0.00%)  0
Weight loss  1  2/8 (25.00%)  2 0/7 (0.00%)  0
Infections and infestations     
Febrile neutropenia  1 [1]  2/8 (25.00%)  2 0/7 (0.00%)  0
Infection: Infection (documented clinically or microbiologically)  1 [2]  1/8 (12.50%)  1 0/7 (0.00%)  0
Infection: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils  1 [3]  1/8 (12.50%)  1 0/7 (0.00%)  0
Infection: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils  1 [4]  1/8 (12.50%)  1 0/7 (0.00%)  0
Infection with unknown ANC: Wound  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Bilirubin (hyperbilirubinemia)  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Creatinine  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Renal and urinary disorders     
Obstruction, GU:Ureter  1  0/8 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Pleural effusion (non-malignant)  1  2/8 (25.00%)  2 0/7 (0.00%)  0
Vascular disorders     
Thrombosis/thrombus/embolism  1  1/8 (12.50%)  1 0/7 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
(fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0x10e9/L, fever >=38.5 degrees C)
[2]
with Grade 3 or 4 neutrophils (ANC <1.0x10e9/L):Blood
[3]
(ANC <1.0x10e9/L):Lung (pneumonia)
[4]
(ANC <1.0x10e9/L):Pelvis NOS
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Surgery + HIPEC + Systemic Chemotherapy Systemic Chemotherapy Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      5/7 (71.43%)    
Blood and lymphatic system disorders     
Edema: limb  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Hemoglobin  1  2/8 (25.00%)  2 1/7 (14.29%)  1
Neutrophils/granulocytes (ANC/AGC)  1  4/8 (50.00%)  5 0/7 (0.00%)  0
Platelets  1  1/8 (12.50%)  7 1/7 (14.29%)  1
Cardiac disorders     
Supraventricular and nodal arrhythmia - Atrial fibrillation  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Gastrointestinal disorders     
Dehydration  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Diarrhea  1  0/8 (0.00%)  0 2/7 (28.57%)  2
Distention, bloating, abdominal  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Nausea  1  2/8 (25.00%)  3 2/7 (28.57%)  2
Pain:Abdomen NOS  1  1/8 (12.50%)  1 1/7 (14.29%)  1
Vomiting  1  1/8 (12.50%)  1 1/7 (14.29%)  11
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  0/8 (0.00%)  0 2/7 (28.57%)  2
Weight loss  1  2/8 (25.00%)  2 0/7 (0.00%)  0
Infections and infestations     
Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: Upper airway NOS  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Infection: Infection with normal ANC or Grade 1 or 2 neutrophils: Urinary tract NOS  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Metabolism and nutrition disorders     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  2/8 (25.00%)  2 0/7 (0.00%)  0
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  6/8 (75.00%)  6 0/7 (0.00%)  0
Bilirubin (hyperbilirubinemia)  1  1/8 (12.50%)  1 0/7 (0.00%)  0
CPK (creatine phosphokinase)  1  4/8 (50.00%)  4 0/7 (0.00%)  0
Phosphate, serum-low (hypophospatemia)  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Sodium, serum-low (hyponatremia)  1  1/8 (12.50%)  1 0/7 (0.00%)  0
Nervous system disorders     
Neurology - Other (Specify, tingling hands/feet)  1  0/8 (0.00%)  0 1/7 (14.29%)  1
Neuropathy: sensory  1  2/8 (25.00%)  2 2/7 (28.57%)  2
Skin and subcutaneous tissue disorders     
Hair loss/alopecia (scalp or body)  1  0/8 (0.00%)  0 1/7 (14.29%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Udo Rudloff
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-3098
Responsible Party: Udo Rudloff, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00941655     History of Changes
Other Study ID Numbers: 090189
09-C-0189
First Submitted: July 16, 2009
First Posted: July 17, 2009
Results First Submitted: April 25, 2013
Results First Posted: July 11, 2013
Last Update Posted: October 3, 2017