ID

15805

Description

Treating Peritoneal Carcinomatosis With PIPAC; ODM derived from: https://clinicaltrials.gov/show/NCT02320448

Link

https://clinicaltrials.gov/show/NCT02320448

Keywords

Versions (1)
  1. 6/14/16 6/14/16 -
Uploaded on

June 14, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Peritoneal Carcinomatosis NCT02320448

English

Eligibility Peritoneal Carcinomatosis NCT02320448

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical and radiological evidence of peritoneal carcinomatosis.
Description

Carcinomatosis of peritoneal cavity

Data type

boolean

Alias
UMLS CUI [1]
C0346990
no indication for standard chemotherapy which prolongs overall survival for at least three months.
Description

No indication of Chemotherapy | Survival time

Data type

boolean

Alias
UMLS CUI [1,1]
C0521090
UMLS CUI [1,2]
C0392920
UMLS CUI [2]
C2919552
performance status 0-2 and life expectancy of more than 3 months.
Description

performance status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C1518965
UMLS CUI [2]
C0023671
age > 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
written informed consent must be obtained according to the local ethics committee requirements.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
extraabdominal metastatic disease.
Description

Metastatic Neoplasm Abdomen outside

Data type

boolean

Alias
UMLS CUI [1,1]
C2939420
UMLS CUI [1,2]
C0000726
UMLS CUI [1,3]
C0205101
symptomatic small bowel obstruction (total parenteral nutrition, nasogastric tube).
Description

Small bowel obstruction Symptomatic | Parenteral Nutrition, Total | Nasogastric tube

Data type

boolean

Alias
UMLS CUI [1,1]
C0235329
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0030548
UMLS CUI [3]
C0085678
chemotherapy or surgery within the last four weeks prior to the first pipac application.
Description

Chemotherapy | Operative Surgical Procedures | Therapy, Investigational

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0543467
UMLS CUI [3]
C0949266
previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
Description

Prior Therapy Cumulative Dose Maximum | Doxorubicin | Daunorubicin | Epirubicin | Idarubicin | Anthracyclines | Anthraquinones

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0806909
UMLS CUI [2]
C0013089
UMLS CUI [3]
C0011015
UMLS CUI [4]
C0014582
UMLS CUI [5]
C0020789
UMLS CUI [6]
C0282564
UMLS CUI [7]
C0003174
a history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin.
Description

Allergic Reaction Cisplatin | Allergic Reaction Platinum-containing Compounds | Allergic Reaction Doxorubicin

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0008838
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C2266854
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0013089
renal impairment, defined as gfr < 60 ml/min.
Description

Renal Insufficiency | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0017654
myocardial insufficiency, defined as nyha class > 2.
Description

myocardial; deficiency | New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1401079
UMLS CUI [2]
C1275491
impaired liver function defined as bilirubin ≥ 1,5 x unl (upper normal limit).
Description

Liver Dysfunction | Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1278039
inadequate haematological function defined as anc ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
Description

Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0205412
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
Description

Condition At risk Patient | Therapeutic procedure At risk Patient | Condition Interferes with Study Protocol | Therapeutic procedure Interferes with Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348563
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348563
previous intraabdominal chemotherapy or intraabdominal antibody therapy.
Description

Prior Chemotherapy intraabdominal | antibody therapy intraabdominal Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0230168
UMLS CUI [2,1]
C0281176
UMLS CUI [2,2]
C0230168
UMLS CUI [2,3]
C0205156
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Similar models

Eligibility Peritoneal Carcinomatosis NCT02320448

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Carcinomatosis of peritoneal cavity
Item
clinical and radiological evidence of peritoneal carcinomatosis.
boolean
C0346990 (UMLS CUI [1])
No indication of Chemotherapy | Survival time
Item
no indication for standard chemotherapy which prolongs overall survival for at least three months.
boolean
C0521090 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C2919552 (UMLS CUI [2])
performance status | Life Expectancy
Item
performance status 0-2 and life expectancy of more than 3 months.
boolean
C1518965 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed consent
Item
written informed consent must be obtained according to the local ethics committee requirements.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic Neoplasm Abdomen outside
Item
extraabdominal metastatic disease.
boolean
C2939420 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
C0205101 (UMLS CUI [1,3])
Small bowel obstruction Symptomatic | Parenteral Nutrition, Total | Nasogastric tube
Item
symptomatic small bowel obstruction (total parenteral nutrition, nasogastric tube).
boolean
C0235329 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0030548 (UMLS CUI [2])
C0085678 (UMLS CUI [3])
Chemotherapy | Operative Surgical Procedures | Therapy, Investigational
Item
chemotherapy or surgery within the last four weeks prior to the first pipac application.
boolean
C0392920 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Prior Therapy Cumulative Dose Maximum | Doxorubicin | Daunorubicin | Epirubicin | Idarubicin | Anthracyclines | Anthraquinones
Item
previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
boolean
C1514463 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0013089 (UMLS CUI [2])
C0011015 (UMLS CUI [3])
C0014582 (UMLS CUI [4])
C0020789 (UMLS CUI [5])
C0282564 (UMLS CUI [6])
C0003174 (UMLS CUI [7])
Allergic Reaction Cisplatin | Allergic Reaction Platinum-containing Compounds | Allergic Reaction Doxorubicin
Item
a history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin.
boolean
C1527304 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C2266854 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0013089 (UMLS CUI [3,2])
Renal Insufficiency | Glomerular Filtration Rate
Item
renal impairment, defined as gfr < 60 ml/min.
boolean
C1565489 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
myocardial; deficiency | New York Heart Association Classification
Item
myocardial insufficiency, defined as nyha class > 2.
boolean
C1401079 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
Liver Dysfunction | Serum total bilirubin measurement
Item
impaired liver function defined as bilirubin ≥ 1,5 x unl (upper normal limit).
boolean
C0086565 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement
Item
inadequate haematological function defined as anc ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
boolean
C0221130 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Condition At risk Patient | Therapeutic procedure At risk Patient | Condition Interferes with Study Protocol | Therapeutic procedure Interferes with Study Protocol
Item
any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Prior Chemotherapy intraabdominal | antibody therapy intraabdominal Previous
Item
previous intraabdominal chemotherapy or intraabdominal antibody therapy.
boolean
C1514457 (UMLS CUI [1,1])
C0230168 (UMLS CUI [1,2])
C0281176 (UMLS CUI [2,1])
C0230168 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
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