Trial · NCT00004547

Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy

NCT00004547, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2011-11-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy. Trials, record NCT00004547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00004547

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy
NCT number: NCT00004547
Status: Completed
Phases: Phase 2
Enrollment: 188 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Abdominal Neoplasm, Colonic Neoplasm, Mesothelioma, Peritoneal Neoplasm
Interventions: Surgery, Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin, Postoperative dwell with paclitaxel and 5-FU
First posted: 2000-02-04
Last updated: 2015-11-18
Results first posted: 2011-11-22

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Disease-free Survival	On study date until the first scan with imageable disease, assessed up to 100 months or more.	Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.
Primary	Number of Participants With a Response	Patients were assessed every three months for one year and then every 6 months	Response is assessed by measuring the time to clinical or radiographic recurrence of disease. Patients will be followed with computed tomography (CT) scans. At any time point where there is evidence of progressive disease in the peritoneal cavity (imageable tumor nodules or new onset of ascites) the patients will be scored as failing within the abdominal cavity.
Primary	Number of Participants With Adverse Events	only assessed during the perioperative period (i.e. up to 90 days following surgery)	Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Secondary	Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed	Perioperative day 7-12 after surgery	Paclitaxel and 5-FU levels in plasma and perfusate will be determined by standard high-performance liquid chromatography (HPLC). Samples will be collected just prior to (Time 0) the infusion of the intraperitoneal dwell of 5-FU and paclitaxel, at the following time intervals after the conclusion of the intraperitoneal dwell infusion (15 minutes, 1 hour, 6 hour, 12 hour, 24 hour, 48 hour).
Secondary	Quality of Life Questionnaire Score	preop, 6 weeks postop and then 3, 6, 9, and 12 months the first year and then every 6 months until the patient is off study	The Short-Form-36 Health Survey (SF-36) and the Functional Assessment of Cancer Therapy Disease Specific for Colorectal Cancer (FACT-C) will be given to the patients upon admission preoperatively, then 6 weeks postoperatively, and then 3, 6, 9, and 12 months for the first year and then every 6 months until the patient goes off study. These forms summarize a participants positive and negative aspects that characterize one's psychological (emotional(, physical, and social well-being at a point in time. For detailed information about the questionnaires, please see the Protocol Link module.
Secondary	Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue	once during surgery	Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Disease-free Survival	On study date until the first scan with imageable disease, assessed up to 100 months or more.	This outcome measure was not analyzed because information was not consistently available.
PRIMARY	Number of Participants With a Response	Patients were assessed every three months for one year and then every 6 months		Participants	NUMBER
PRIMARY	Number of Participants With Adverse Events	only assessed during the perioperative period (i.e. up to 90 days following surgery)	188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P. Meso + 48 L. Grade + 57 Adeno. = 188).	Participants	NUMBER
SECONDARY	Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed	Perioperative day 7-12 after surgery	This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).
SECONDARY	Quality of Life Questionnaire Score	preop, 6 weeks postop and then 3, 6, 9, and 12 months the first year and then every 6 months until the patient is off study	This outcome measure was not evaluated due to poor patient compliance.
SECONDARY	Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue	once during surgery	This outcome measure was not analyzed because it was not feasible.

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants With a Response	Peritoneal Mesothelioma	24	Participants
Number of Participants With a Response	Low Grade Mucinous Adenocarcinoma	18	Participants
Number of Participants With a Response	Adenocarcinoma of Gastrointestinal Origin	6	Participants
Number of Participants With Adverse Events	Mesothelioma, Low Grade, and Adenocarcinoma	73	Participants

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Peritoneal Mesothelioma	83
Overall Study	STARTED	Low Grade Mucinous Adenocarcinoma	48
Overall Study	STARTED	Adenocarcinoma of Gastrointestinal Origin	57
Overall Study	Not Evaluable	Peritoneal Mesothelioma	21
Overall Study	Not Evaluable	Low Grade Mucinous Adenocarcinoma	9
Overall Study	Not Evaluable	Adenocarcinoma of Gastrointestinal Origin	23
Overall Study	COMPLETED	Peritoneal Mesothelioma	61
Overall Study	COMPLETED	Low Grade Mucinous Adenocarcinoma	39
Overall Study	COMPLETED	Adenocarcinoma of Gastrointestinal Origin	35
Overall Study	NOT COMPLETED	Peritoneal Mesothelioma	22

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Sinus ventricular tachycardia (SVT)	Cardiac disorders	Mesothelioma, Low Grade, and Adenocarcinoma	2	188	2
serious	ascites	Gastrointestinal disorders	Mesothelioma, Low Grade, and Adenocarcinoma	2	188	2
serious	atrial fibrillation	Cardiac disorders	Mesothelioma, Low Grade, and Adenocarcinoma	1	188	1
serious	cholecystitis	Hepatobiliary disorders	Mesothelioma, Low Grade, and Adenocarcinoma	1	188	1
serious	colitis	Gastrointestinal disorders	Mesothelioma, Low Grade, and Adenocarcinoma	1	188	1
serious	colon perforation	Gastrointestinal disorders	Mesothelioma, Low Grade, and Adenocarcinoma	2	188	2
serious	diarrhea	Gastrointestinal disorders	Mesothelioma, Low Grade, and Adenocarcinoma	1	188	1
serious	Deep venous thrombosis (DVT)	Vascular disorders	Mesothelioma, Low Grade, and Adenocarcinoma	1	188	1
serious	Enterocutaneous fistula	Gastrointestinal disorders	Mesothelioma, Low Grade, and Adenocarcinoma	2	188	2
serious	Gastric perforation	Gastrointestinal disorders	Mesothelioma, Low Grade, and Adenocarcinoma	1	188	1

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mesothelioma, Low Grade, and Adenocarcinoma
Total, other adverse events	Mesothelioma, Low Grade, and Adenocarcinoma	2	188
Total, serious adverse events	Mesothelioma, Low Grade, and Adenocarcinoma	71	188

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
626987	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00004547

GET https://conductscience.org/api/trials/v1/NCT00004547/events?page=2

API reference For AI assistants