ID

18467

Description

A Study of OGX-011/Gemcitabine/Platinum-Based Regimen in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00138658

Link

https://clinicaltrials.gov/show/NCT00138658

Keywords

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

November 6, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00138658

English

Eligibility Non-small Cell Lung Cancer NCT00138658

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have a histologically or cytologically confirmed diagnosis of nsclc and must not have had chemotherapy or biological therapy for their disease.
Description

Non-Small Cell Lung Carcinoma | Chemotherapy Disease | Biological Response Modifier Therapy Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C0005527
UMLS CUI [3,2]
C0012634
2. stage iiib (n3 and/or pleural or pericardial effusion) or iv disease that is not amenable to either surgery or radiation therapy of curative intent.
Description

TNM clinical staging | Pleural effusion disorder | Pericardial effusion | Disease Amenable Operative Surgical Procedures | Disease Amenable Therapeutic radiology procedure Curative intent

Data type

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0031039
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C3900053
UMLS CUI [4,3]
C0543467
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C3900053
UMLS CUI [5,3]
C1522449
UMLS CUI [5,4]
C1276305
3. life expectancy of ≥ 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
4. if patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.
Description

prior radiation therapy | Therapeutic radiology procedure Lesion | Lesion Use of Evaluating response to treatment | Lesion Increased size | Toxic effect Due to Therapeutic radiology procedure | Patient Recovered

Data type

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0221198
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1524063
UMLS CUI [3,3]
C0184781
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0332509
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C1522449
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C0521108
5. radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.
Description

Therapeutic radiology procedure Completed Lesion Quantity | Evaluating response to treatment | Therapeutic radiology procedure Completed Site

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0221198
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0184781
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C1515974
6. at least one unidimensionally measurable lesion meeting response evaluation criteria in solid tumors [recist] (at least 10 mm in longest diameter by spiral computed tomography [ct] scan, or at least 20 mm by standard techniques).
Description

Measurable Disease Linear Quantity | Measurable Disease Longest Diameter | Tomography, Spiral Computed | Measurement technique Standard

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0552406
UMLS CUI [3]
C0860888
UMLS CUI [4,1]
C0242485
UMLS CUI [4,2]
C1442989
7. ecog status must be ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior chemotherapy or biological therapy (approved or experimental) for nsclc, including adjuvant and neoadjuvant treatment.
Description

Prior Chemotherapy Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Approved Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Investigational Non-Small Cell Lung Carcinoma | Adjuvant therapy Non-Small Cell Lung Carcinoma | Neoadjuvant Therapy Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C0005527
UMLS CUI [2,2]
C0205540
UMLS CUI [2,3]
C0007131
UMLS CUI [3,1]
C0005527
UMLS CUI [3,2]
C1517586
UMLS CUI [3,3]
C0007131
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0007131
UMLS CUI [5,1]
C0600558
UMLS CUI [5,2]
C0007131
2. presence of central nervous system (cns) metastases, unless the patient has completed successful local therapy for cns metastases, with the exception of leptomeningeal disease for which patients will be excluded. patients must be off corticosteroids for at least 21 days prior to starting treatment.
Description

CNS metastases | Local Therapy Completed CNS metastases | Leptomeningeal disease | Adrenal Cortex Hormones Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C1517925
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0686377
UMLS CUI [3]
C3160796
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C1444662
3. second primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 3 years previously with no evidence of recurrence).
Description

Second Primary Cancer | Carcinoma in situ of uterine cervix | Skin carcinoma Treated | Malignant neoplasm of prostate Localized Clinical | Carcinoma of urinary bladder, superficial | Malignant Neoplasm Treated | Recurrence Evidence

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0851140
UMLS CUI [3,1]
C0699893
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0376358
UMLS CUI [4,2]
C0392752
UMLS CUI [4,3]
C0205210
UMLS CUI [5]
C1336527
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C1522326
UMLS CUI [7,1]
C2825055
UMLS CUI [7,2]
C3887511
4. patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (this criteria is intended to exclude patients with stage iiib disease, as defined by the presence of n3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)
Description

Indication Combined Modality Therapy Curative intent | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures | TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0009429
UMLS CUI [1,3]
C1276305
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0543467
UMLS CUI [5]
C3258246
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00138658

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Chemotherapy Disease | Biological Response Modifier Therapy Disease
Item
1. patients must have a histologically or cytologically confirmed diagnosis of nsclc and must not have had chemotherapy or biological therapy for their disease.
boolean
C0007131 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0005527 (UMLS CUI [3,1])
C0012634 (UMLS CUI [3,2])
TNM clinical staging | Pleural effusion disorder | Pericardial effusion | Disease Amenable Operative Surgical Procedures | Disease Amenable Therapeutic radiology procedure Curative intent
Item
2. stage iiib (n3 and/or pleural or pericardial effusion) or iv disease that is not amenable to either surgery or radiation therapy of curative intent.
boolean
C3258246 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C0031039 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C3900053 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
Life Expectancy
Item
3. life expectancy of ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
prior radiation therapy | Therapeutic radiology procedure Lesion | Lesion Use of Evaluating response to treatment | Lesion Increased size | Toxic effect Due to Therapeutic radiology procedure | Patient Recovered
Item
4. if patient has had prior radiation therapy: lesion(s) used for determination of response was not previously irradiated or has increased in size since the completion of radiotherapy; and patient has recovered from any toxicity from the radiotherapy.
boolean
C0279134 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
C0221198 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0184781 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C0332509 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C0030705 (UMLS CUI [6,1])
C0521108 (UMLS CUI [6,2])
Therapeutic radiology procedure Completed Lesion Quantity | Evaluating response to treatment | Therapeutic radiology procedure Completed Site
Item
5. radiotherapy to lesion(s) used for determination of response was completed at least 6 weeks prior to treatment; radiotherapy to other sites was completed at least 2 weeks prior to treatment.
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0184781 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
Measurable Disease Linear Quantity | Measurable Disease Longest Diameter | Tomography, Spiral Computed | Measurement technique Standard
Item
6. at least one unidimensionally measurable lesion meeting response evaluation criteria in solid tumors [recist] (at least 10 mm in longest diameter by spiral computed tomography [ct] scan, or at least 20 mm by standard techniques).
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
C0860888 (UMLS CUI [3])
C0242485 (UMLS CUI [4,1])
C1442989 (UMLS CUI [4,2])
ECOG performance status
Item
7. ecog status must be ≤ 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Approved Non-Small Cell Lung Carcinoma | Biological Response Modifier Therapy Investigational Non-Small Cell Lung Carcinoma | Adjuvant therapy Non-Small Cell Lung Carcinoma | Neoadjuvant Therapy Non-Small Cell Lung Carcinoma
Item
1. prior chemotherapy or biological therapy (approved or experimental) for nsclc, including adjuvant and neoadjuvant treatment.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0005527 (UMLS CUI [2,1])
C0205540 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C0005527 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0007131 (UMLS CUI [3,3])
C0677850 (UMLS CUI [4,1])
C0007131 (UMLS CUI [4,2])
C0600558 (UMLS CUI [5,1])
C0007131 (UMLS CUI [5,2])
CNS metastases | Local Therapy Completed CNS metastases | Leptomeningeal disease | Adrenal Cortex Hormones Discontinued
Item
2. presence of central nervous system (cns) metastases, unless the patient has completed successful local therapy for cns metastases, with the exception of leptomeningeal disease for which patients will be excluded. patients must be off corticosteroids for at least 21 days prior to starting treatment.
boolean
C0686377 (UMLS CUI [1])
C1517925 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0686377 (UMLS CUI [2,3])
C3160796 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
Second Primary Cancer | Carcinoma in situ of uterine cervix | Skin carcinoma Treated | Malignant neoplasm of prostate Localized Clinical | Carcinoma of urinary bladder, superficial | Malignant Neoplasm Treated | Recurrence Evidence
Item
3. second primary malignancy (except in situ carcinoma of the cervix, adequately treated non-melanomatous skin cancers, clinically localized prostate cancer, superficial bladder cancer or other malignancy treated at least 3 years previously with no evidence of recurrence).
boolean
C0751623 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0699893 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0376358 (UMLS CUI [4,1])
C0392752 (UMLS CUI [4,2])
C0205210 (UMLS CUI [4,3])
C1336527 (UMLS CUI [5])
C0006826 (UMLS CUI [6,1])
C1522326 (UMLS CUI [6,2])
C2825055 (UMLS CUI [7,1])
C3887511 (UMLS CUI [7,2])
Indication Combined Modality Therapy Curative intent | Chemotherapy | Therapeutic radiology procedure | Operative Surgical Procedures | TNM clinical staging
Item
4. patients eligible for combined modality therapy with curative intent as defined by the combination of chemotherapy, radiation therapy and/or surgery. (this criteria is intended to exclude patients with stage iiib disease, as defined by the presence of n3 nodal status, who have been reported to have cure rates as high as 10% when treated with combined modality therapy.)
boolean
C3146298 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C3258246 (UMLS CUI [5])
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