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Trial record 20 of 141 for:    appendix cancer

Debulking and Chemotherapy With or Without Intraperitoneal Chemotherapy to Treat Peritoneal Carcinomatosis

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ClinicalTrials.gov Identifier: NCT00052962
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 19, 2012
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
Marybeth Hughes, 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 Gastrointestinal Neoplasm
Interventions Procedure: Cytoreductive surgery
Procedure: Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Surgery + Post op Chemotherapy Arm 2 Surgery + CHPP
Hide Arm/Group Description
  • Cytoreductive surgery
  • Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.

Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy

  • Cytoreductive surgery
  • continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
  • post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
  • post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Period Title: Overall Study
Started 13 17
Completed 12 15
Not Completed 1 2
Reason Not Completed
Not evaluable             0             2
Not randomized/not evaluable             1             0
Arm/Group Title Arm 1 Surgery + Post op Chemotherapy Arm 2 Surgery + CHPP Total
Hide Arm/Group Description
  • Cytoreductive surgery
  • Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.

Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy

  • Cytoreductive surgery
  • continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
  • post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
  • post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Total of all reporting groups
Overall Number of Baseline Participants 13 17 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 17 participants 30 participants
<=18 years 0 0 0
Between 18 and 65 years 11 15 26
>=65 years 2 0 2
[1]
Measure Description: Two subject's were not evaluable, and/or information is not known for Arm 2.
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 17 participants 30 participants
51.08  (15.58) 48.64  (11.21) 50.55  (13.14)
[1]
Measure Description: Mean values were not calculated for all participants who started the study because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 17 participants 30 participants
Female
6
  46.2%
7
  41.2%
13
  43.3%
Male
7
  53.8%
10
  58.8%
17
  56.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 17 participants 30 participants
Hispanic or Latino
2
  15.4%
1
   5.9%
3
  10.0%
Not Hispanic or Latino
11
  84.6%
16
  94.1%
27
  90.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants 17 participants 30 participants
American Indian or Alaska Native 0 0 0
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 1 3 4
White 10 13 23
More than one race 0 0 0
Unknown or Not Reported 0 0 0
Hispanic 2 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 17 participants 30 participants
13 17 30
1.Primary Outcome
Title Progression Free Survival
Hide Description

CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter.

Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans.

Time Frame 2003-2008
Hide Outcome Measure Data
Hide Analysis Population Description
Study was closed July 2008 because the PI left the institution, thus the objective was not met.
Arm/Group Title Arm 1 Surgery + Post op Chemotherapy Arm 2 Surgery + CHPP
Hide Arm/Group Description:
  • Cytoreductive surgery
  • Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.

Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy

  • Cytoreductive surgery
  • continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
  • post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
  • post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With an Adverse Event
Hide Description Here is the number of participants with an adverse event. For a detailed list of adverse events see the adverse event module.
Time Frame 2003-2008
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were not included in the analysis because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
Arm/Group Title Arm 1 Surgery + Post op Chemotherapy Arm 2 Surgery + CHPP
Hide Arm/Group Description:
  • Cytoreductive surgery
  • Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.

Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy

  • Cytoreductive surgery
  • continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
  • post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
  • post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
Overall Number of Participants Analyzed 13 14
Measure Type: Number
Unit of Measure: Participants
7 6
Time Frame [Not Specified]
Adverse Event Reporting Description Three participants were no included in the assessment because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.
 
Arm/Group Title Arm 1 Surgery + Post op Chemotherapy Arm 2 Surgery + CHPP
Hide Arm/Group Description
  • Cytoreductive surgery
  • Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.

Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy

  • Cytoreductive surgery
  • continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin
  • post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2
  • post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}.
All-Cause Mortality
Arm 1 Surgery + Post op Chemotherapy Arm 2 Surgery + CHPP
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Surgery + Post op Chemotherapy Arm 2 Surgery + CHPP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/13 (38.46%)      6/14 (42.86%)    
Gastrointestinal disorders     
Ileus, wound infection  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Fistula intestinal  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Partial small bowel obstruction  1  0/13 (0.00%)  0 1/14 (7.14%)  1
Post-op ileus  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Bowel perforation  1  0/13 (0.00%)  0 1/14 (7.14%)  1
Hepatobiliary disorders     
AST  1  1/13 (7.69%)  1 0/14 (0.00%)  0
ALT/AST  1  1/13 (7.69%)  1 1/14 (7.14%)  1
Infections and infestations     
Sepsis  1  0/13 (0.00%)  0 1/14 (7.14%)  1
Wound infection  1  0/13 (0.00%)  0 1/14 (7.14%)  1
Wound infection (superficial)  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Metabolism and nutrition disorders     
Lipase gr  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Reproductive system and breast disorders     
Abd pain  1  0/13 (0.00%)  0 1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders     
Pleural effusion/non-malignant  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Bilateral pleural effusion, bibasilar atelectasis, pelvic fluid  1  0/13 (0.00%)  0 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Surgery + Post op Chemotherapy Arm 2 Surgery + CHPP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      0/14 (0.00%)    
Cardiac disorders     
SVT  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Renal and urinary disorders     
UTI  1  1/13 (7.69%)  1 0/14 (0.00%)  0
UTI: pyelonephritis  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleural effusion post op  1  1/13 (7.69%)  1 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCv2.0
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
Layout table for Results Point of Contact information
Name/Title: Marybeth Hughes, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-594-9341
EMail: hughesm@mail.nih.gov
Layout table for additonal information
Responsible Party: Marybeth Hughes, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00052962     History of Changes
Obsolete Identifiers: NCT00056108
Other Study ID Numbers: 030085
03-C-0085
First Submitted: January 26, 2003
First Posted: January 27, 2003
Results First Submitted: September 4, 2012
Results First Posted: November 19, 2012
Last Update Posted: November 22, 2012