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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Marybeth Hughes, National Institutes of Health Clinical Center (CC)

ClinicalTrials.gov Identifier:

NCT00052962

First received: January 26, 2003

Last updated: November 16, 2012

Last verified: November 2012

History of Changes

Results First Received: September 4, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Gastrointestinal Neoplasm
Interventions:	Procedure: Cytoreductive surgery Procedure: Continuous hyperthermic peritoneal perfusion (HIPEC/CHPP)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Arm 1 Surgery + Post op Chemotherapy	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 + CHPP	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}.

Description

Arm 1 Surgery + Post op Chemotherapy

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 + CHPP

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}.

Participant Flow: Overall Study

	Arm 1 Surgery + Post op Chemotherapy	Arm 2 Surgery + CHPP
STARTED	13	17
COMPLETED	12	15
NOT COMPLETED	1	2
Not evaluable	0	2
Not randomized/not evaluable	1	0

Baseline Characteristics

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Reporting Groups

	Description
Arm 1 Surgery + Post op Chemotherapy	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 + CHPP	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	Total of all reporting groups

Description

Arm 1 Surgery + Post op Chemotherapy

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 + CHPP

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

Total of all reporting groups

Baseline Measures

	Arm 1 Surgery + Post op Chemotherapy	Arm 2 Surgery + CHPP	Total
Number of Participants [units: participants]	13	17	30
Age ^[1] [units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	11	15	26
>=65 years	2	0	2
Age ^[2] [units: years] Mean ± Standard Deviation	51.08 ± 15.58	48.64 ± 11.21	50.55 ± 13.14
Gender [units: participants]
Female	6	7	13
Male	7	10	17
Ethnicity (NIH/OMB) [units: Participants]
Hispanic or Latino	2	1	3
Not Hispanic or Latino	11	16	27
Unknown or Not Reported	0	0	0
Race/Ethnicity, Customized [units: 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 [units: participants]
United States	13	17	30

[1]	Two subject's were not evaluable, and/or information is not known for Arm 2.
[2]	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.

Outcome Measures

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1. Primary:

Progression Free Survival [ Time Frame: 2003-2008 ]

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2. Secondary:

Number of Participants With an Adverse Event [ Time Frame: 2003-2008 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Marybeth Hughes, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-594-9341
e-mail: hughesm@mail.nih.gov

Publications:

Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, Jandik P, Iveson T, Carmichael J, Alakl M, Gruia G, Awad L, Rougier P. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000 Mar 25;355(9209):1041-7.

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
Study First Received:	January 26, 2003
Results First Received:	September 4, 2012
Last Updated:	November 16, 2012
Health Authority:	United States: Federal Government

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