ID

15805

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT02320448

Keywords

  1. 14/06/16 14/06/16 -
Caricato su

14 giugno 2016

DOI

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Licenza

Creative Commons BY 4.0

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Eligibility Peritoneal Carcinomatosis NCT02320448

Eligibility Peritoneal Carcinomatosis NCT02320448

Inclusion Criteria
Descrizione

Inclusion Criteria

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

Carcinomatosis of peritoneal cavity

Tipo di dati

boolean

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

No indication of Chemotherapy | Survival time

Tipo di dati

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.
Descrizione

performance status | Life Expectancy

Tipo di dati

boolean

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

Age

Tipo di dati

boolean

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

Informed consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
extraabdominal metastatic disease.
Descrizione

Metastatic Neoplasm Abdomen outside

Tipo di dati

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).
Descrizione

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

Tipo di dati

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.
Descrizione

Chemotherapy | Operative Surgical Procedures | Therapy, Investigational

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Renal Insufficiency | Glomerular Filtration Rate

Tipo di dati

boolean

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

myocardial; deficiency | New York Heart Association Classification

Tipo di dati

boolean

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

Liver Dysfunction | Serum total bilirubin measurement

Tipo di dati

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.
Descrizione

Hematologic function Inadequate | Absolute neutrophil count | Platelet Count measurement

Tipo di dati

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.
Descrizione

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

Tipo di dati

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.
Descrizione

Prior Chemotherapy intraabdominal | antibody therapy intraabdominal Previous

Tipo di dati

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

Similar models

Eligibility Peritoneal Carcinomatosis NCT02320448

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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