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← Peritoneal Neoplasm

NCT00004547 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.

This outcome measure was not analyzed because information was not consistently available.

→

primary · POSTED

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.

Source null

→

primary · POSTED

Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

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).

→

secondary · POSTED

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).

This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).

→

secondary · POSTED

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.

This outcome measure was not evaluated due to poor patient compliance.

→

secondary · POSTED

Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.

This outcome measure was not analyzed because it was not feasible.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Quality of Life Questionnaire Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-peritoneal-neoplasm
nct id
NCT00004547
qol key
qol-0004
source section id
NCT00004547-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact-c' in the study's own wording
scale title
Quality of Life Questionnaire Score
measure definition
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.
time frame
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
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
This outcome measure was not evaluated due to poor patient compliance.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-peritoneal-neoplasm
nct id
NCT00004547
trial label
Treatment of Peritoneal Cancer With Surgery, Perfused Heated Cisplatin and Chemotherapy
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0000
    source section id
    NCT00004547-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Disease-free Survival
    endpoint definition
    Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.
    time origin
    On study date until the first scan with imageable disease, assessed up to 100 months or more.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome measure was not analyzed because information was not consistently available.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0001
    source section id
    NCT00004547-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With a Response
    endpoint definition
    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.
    time origin
    Patients were assessed every three months for one year and then every 6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0002
    source section id
    NCT00004547-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Adverse Events
    endpoint definition
    Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
    time origin
    only assessed during the perioperative period (i.e. up to 90 days following surgery)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0003
    source section id
    NCT00004547-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed
    endpoint definition
    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).
    time origin
    Perioperative day 7-12 after surgery
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0004
    source section id
    NCT00004547-om-0004
    source outcome index
    4
    endpoint
    Quality of Life Questionnaire Score
    endpoint definition
    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.
    time origin
    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
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome measure was not evaluated due to poor patient compliance.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0005
    source section id
    NCT00004547-om-0005
    source outcome index
    5
    endpoint
    Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue
    endpoint definition
    Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.
    time origin
    once during surgery
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This outcome measure was not analyzed because it was not feasible.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Peritoneal Mesothelioma
    regimen
    Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Low Grade Mucinous Adenocarcinoma
    regimen
    Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Adenocarcinoma of Gastrointestinal Origin
    regimen
    Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Peritoneal Mesothelioma
    regimen
    Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
    analyzed count
    83
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Low Grade Mucinous Adenocarcinoma
    regimen
    Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
    analyzed count
    48
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Adenocarcinoma of Gastrointestinal Origin
    regimen
    Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
    analyzed count
    57
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Mesothelioma, Low Grade, and Adenocarcinoma
    regimen
    Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
    analyzed count
    188
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Peritoneal Mesothelioma
    regimen
    Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0003#groups/OG000
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Low Grade Mucinous Adenocarcinoma
    regimen
    Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0003#groups/OG001
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Adenocarcinoma of Gastrointestinal Origin
    regimen
    Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0003#groups/OG002
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Peritoneal Mesothelioma
    regimen
    Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0004#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Low Grade Mucinous Adenocarcinoma
    regimen
    Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00004547-om-0004#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    harm key
    EG000
    source section id
    NCT00004547-ae
    event group key
    EG000
    event group label
    Mesothelioma, Low Grade, and Adenocarcinoma
    serious affected
    71
    serious at risk
    188
    other affected
    2
    other at risk
    188
    frequency threshold
    0
    collection period
    Source null
    event definition
    Adverse Events: 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).
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-peritoneal-neoplasm
    nct id
    NCT00004547
    qol key
    qol-0004
    source section id
    NCT00004547-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'fact-c' in the study's own wording
    scale title
    Quality of Life Questionnaire Score
    measure definition
    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.
    time frame
    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
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    This outcome measure was not evaluated due to poor patient compliance.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice