ID

22306

Description

The High-Dose Aldesleukin (IL-2) "Select" Trial for Patients With Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00554515

Link

https://clinicaltrials.gov/show/NCT00554515

Keywords

Versions (1)
  1. 5/29/17 5/29/17 -
Uploaded on

May 29, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Renal Cell Carcinoma NCT00554515

English

Eligibility Metastatic Renal Cell Carcinoma NCT00554515

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically confirmed renal cell carcinoma that is metastatic or unresectable.
Description

histologically confirmed renal cell carcinoma, metastatic or unresectable

Data type

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C2939420
UMLS CUI [1,4]
C1336869
if patients have measurable disease restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
Description

measurable disease, solitary mass, cytology/histology

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265601
UMLS CUI [1,3]
C0019638
UMLS CUI [1,4]
C0010819
patients must provide access to tissue blocks containing adequate tumor for interpretation and analysis.
Description

tissue block

Data type

boolean

Alias
UMLS CUI [1,1]
C2316369
UMLS CUI [1,2]
C2317347
patients must have measurable disease.
Description

measurable disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
patients must have good performance status (ecog 0 or 1; karnofsky ps 100-80%).
Description

ecog, karnofsky

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
patients must have adequate organ function.
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
patients must have no contraindication of vasopressor agents.
Description

contraindication vasopressor agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0042397
patients must be ≥ 18 years of age.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received systemic therapy for metastatic disease.
Description

prior chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
patients with organ allografts.
Description

organ allografts

Data type

boolean

Alias
UMLS CUI [1,1]
C1515895
UMLS CUI [1,2]
C0524930
patients who require or are likely to require systemic corticosteroid therapy for intercurrent illness.
Description

systemic corticosteroid therapy

Data type

boolean

Alias
UMLS CUI [1]
C4053960
patients with any significant medical disease other than the malignancy (e.g. copd, patients with ascites or pleural effusions), which in the opinion of the investigator would significantly increase the risk of immunotherapy.
Description

comorbidity, risk, immunotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0021083
patients with a history of another malignancy within the past 5 years other than surgically cured non-melanoma skin cancer, carcinoma-in-situ or stage i carcinoma of the cervix.
Description

history of malignant disease other than surgically cured non-melanoma skin cancer, carcinoma-in-situ or stage i carcinoma of the cervix

Data type

boolean

Alias
UMLS CUI [1]
C0455471
UMLS CUI [2,1]
C0007114
UMLS CUI [2,2]
C0332644
UMLS CUI [3]
C0851140
UMLS CUI [4]
C0278575
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Similar models

Eligibility Metastatic Renal Cell Carcinoma NCT00554515

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
histologically confirmed renal cell carcinoma, metastatic or unresectable
Item
patients must have histologically confirmed renal cell carcinoma that is metastatic or unresectable.
boolean
C0007134 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C2939420 (UMLS CUI [1,3])
C1336869 (UMLS CUI [1,4])
measurable disease, solitary mass, cytology/histology
Item
if patients have measurable disease restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
boolean
C1513041 (UMLS CUI [1,1])
C1265601 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,3])
C0010819 (UMLS CUI [1,4])
tissue block
Item
patients must provide access to tissue blocks containing adequate tumor for interpretation and analysis.
boolean
C2316369 (UMLS CUI [1,1])
C2317347 (UMLS CUI [1,2])
measurable disease
Item
patients must have measurable disease.
boolean
C1513041 (UMLS CUI [1])
ecog, karnofsky
Item
patients must have good performance status (ecog 0 or 1; karnofsky ps 100-80%).
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
organ function
Item
patients must have adequate organ function.
boolean
C0678852 (UMLS CUI [1])
contraindication vasopressor agents
Item
patients must have no contraindication of vasopressor agents.
boolean
C1301624 (UMLS CUI [1,1])
C0042397 (UMLS CUI [1,2])
age
Item
patients must be ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
prior chemotherapy
Item
patients who have received systemic therapy for metastatic disease.
boolean
C1514457 (UMLS CUI [1])
organ allografts
Item
patients with organ allografts.
boolean
C1515895 (UMLS CUI [1,1])
C0524930 (UMLS CUI [1,2])
systemic corticosteroid therapy
Item
patients who require or are likely to require systemic corticosteroid therapy for intercurrent illness.
boolean
C4053960 (UMLS CUI [1])
comorbidity, risk, immunotherapy
Item
patients with any significant medical disease other than the malignancy (e.g. copd, patients with ascites or pleural effusions), which in the opinion of the investigator would significantly increase the risk of immunotherapy.
boolean
C0009488 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0021083 (UMLS CUI [1,3])
history of malignant disease other than surgically cured non-melanoma skin cancer, carcinoma-in-situ or stage i carcinoma of the cervix
Item
patients with a history of another malignancy within the past 5 years other than surgically cured non-melanoma skin cancer, carcinoma-in-situ or stage i carcinoma of the cervix.
boolean
C0455471 (UMLS CUI [1])
C0007114 (UMLS CUI [2,1])
C0332644 (UMLS CUI [2,2])
C0851140 (UMLS CUI [3])
C0278575 (UMLS CUI [4])
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