ID

18453

Description

A Comparison of Two Doses of Pemetrexed in Patients Who Have Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00078260

Link

https://clinicaltrials.gov/show/NCT00078260

Keywords

Versions (2)
  1. 11/6/16 11/6/16 -
  2. 11/7/16 11/7/16 -
Uploaded on

November 6, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Non-Small Cell Lung Cancer NCT00078260

English

Eligibility Non-Small Cell Lung Cancer NCT00078260

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of locally advanced or metastatic (stage iii or iv at entry) non-small cell lung cancer (nsclc) that is not amenable to curative therapy.
Description

Non-Small Cell Lung Carcinoma Advanced Locally Curative treatment Amenable | Non-small cell lung cancer metastatic Curative treatment Amenable | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [1,4]
C1273390
UMLS CUI [1,5]
C3900053
UMLS CUI [2,1]
C0278987
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C3900053
UMLS CUI [3]
C3258246
patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
Description

Prior Chemotherapy Platinum-Based Locally Advanced Malignant Neoplasm | Prior Chemotherapy Platinum-Based Metastatic Neoplasm | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Chemotherapy Additional Recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1514162
UMLS CUI [1,3]
C0677984
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C2939420
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0392920
UMLS CUI [4]
C0085533
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C1524062
UMLS CUI [5,3]
C2825055
no more than two prior systemic anti-cancer therapies will be allowed.
Description

cancer treatment Systemic Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C1265611
prior radiation therapy is allowed to less than 25% of the bone marrow. prior radiation to the whole pelvis is not allowed. prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.
Description

prior radiation therapy Bone Marrow Percentage | prior radiation therapy Whole-Pelvis | prior radiation therapy Completed | Toxic effect Patient Recovered

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C3827467
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0030705
UMLS CUI [4,3]
C0521108
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
breast-feeding.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Description

Second Primary Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0751623
inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
Description

Aspirin Unable to discontinue Period | Non-Steroidal Anti-Inflammatory Agents Unable to discontinue Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C1548265
UMLS CUI [1,3]
C1948053
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1548265
UMLS CUI [2,3]
C1948053
inability or unwillingness to take folic acid or vitamin b12 supplementation.
Description

Folate intake Unwilling | Vitamin B12 supplement Intake Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0564428
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C3661610
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00078260

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma Advanced Locally Curative treatment Amenable | Non-small cell lung cancer metastatic Curative treatment Amenable | TNM clinical staging
Item
diagnosis of locally advanced or metastatic (stage iii or iv at entry) non-small cell lung cancer (nsclc) that is not amenable to curative therapy.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1273390 (UMLS CUI [1,4])
C3900053 (UMLS CUI [1,5])
C0278987 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C3900053 (UMLS CUI [2,3])
C3258246 (UMLS CUI [3])
Prior Chemotherapy Platinum-Based Locally Advanced Malignant Neoplasm | Prior Chemotherapy Platinum-Based Metastatic Neoplasm | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Chemotherapy Additional Recurrence
Item
patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence.
boolean
C1514457 (UMLS CUI [1,1])
C1514162 (UMLS CUI [1,2])
C0677984 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C2939420 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C0085533 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C1524062 (UMLS CUI [5,2])
C2825055 (UMLS CUI [5,3])
cancer treatment Systemic Quantity
Item
no more than two prior systemic anti-cancer therapies will be allowed.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
prior radiation therapy Bone Marrow Percentage | prior radiation therapy Whole-Pelvis | prior radiation therapy Completed | Toxic effect Patient Recovered
Item
prior radiation therapy is allowed to less than 25% of the bone marrow. prior radiation to the whole pelvis is not allowed. prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C3827467 (UMLS CUI [2,2])
C0279134 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0600688 (UMLS CUI [4,1])
C0030705 (UMLS CUI [4,2])
C0521108 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy.
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
breast-feeding.
boolean
C0006147 (UMLS CUI [1])
Second Primary Cancer
Item
second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
boolean
C0751623 (UMLS CUI [1])
Aspirin Unable to discontinue Period | Non-Steroidal Anti-Inflammatory Agents Unable to discontinue Period
Item
inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period.
boolean
C0004057 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
C1948053 (UMLS CUI [2,3])
Folate intake Unwilling | Vitamin B12 supplement Intake Unwilling
Item
inability or unwillingness to take folic acid or vitamin b12 supplementation.
boolean
C0564428 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C3661610 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
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