ID

36670

Beskrivning

A Study Evaluating the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects With Stage III Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02412371

Länk

https://clinicaltrials.gov/show/NCT02412371

Nyckelord

Versioner (1)
  1. 2019-05-31 2019-05-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer Stage III NCT02412371

Engelsk

Eligibility Non-small Cell Lung Cancer Stage III NCT02412371

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. participants with histologically or cytologically confirmed stage iii non-small cell lung cancer (nsclc).
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
2. participants in the randomized portion of the study must have measurable disease per response evaluation criteria in solid tumors (recist), version 1.1 criteria.
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
3. participants must have tumor volume of ≤ 150 cm^3 and v20 (volume of lung to receive 20 gy radiotherapy according to simulation) < 35%.
Beskrivning

Tumor Volume | Lung Volume Measurement Suitable Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0475276
UMLS CUI [2,1]
C0024129
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C1522449
4. participant must have an eastern cooperative oncology group (ecog) performance score of 0 - 1.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. participant must have adequate hematologic, renal, hepatic, and lung function.
Beskrivning

Hematologic function | Renal function | Liver function | Pulmonary function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0231921
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. participants with prior chemotherapy or radiotherapy (rt) for current nsclc. participants curatively treated for past early stage nsclc greater than 3 years ago may be included.
Beskrivning

Prior Chemotherapy Non-Small Cell Lung Carcinoma | Prior radiation therapy Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0007131
2. participants with prior exposure to poly-adp-ribose polymerase (parp) inhibitors.
Beskrivning

Exposure to Poly(ADP-ribose) Polymerase Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1882413
3. participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (cremophor).
Beskrivning

Carboplatin allergy | Paclitaxel allergy | Hypersensitivity POLYOXYETHYLATED CASTOR OIL | Hypersensitivity Cremophor

Datatyp

boolean

Alias
UMLS CUI [1]
C0570701
UMLS CUI [2]
C0570707
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0982061
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0056475
4. participants with prior mediastinal or thoracic radiotherapy. prior tangential rt to prior breast cancer is acceptable.
Beskrivning

Radiotherapy to mediastinum | Radiotherapy to thorax

Datatyp

boolean

Alias
UMLS CUI [1]
C4049191
UMLS CUI [2]
C4038705
5. participants with major surgery in the 4 weeks prior to randomization (video-assisted thoracoscopic surgery (vats) and/or mediastinoscopy is not considered major surgery).
Beskrivning

Major surgery | Exception Video-Assisted Thoracic Surgery | Exception Mediastinoscopy

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0752151
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0025065
6. participants with a previous or concurrent malignancy except for treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient received potentially curative treatment and has been disease-free for 3 years or is considered cured by the investigator if has been disease-free for less than 3 years.
Beskrivning

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Curative treatment Cancer Other | Exception Disease Free Duration | Exception Patient Cured

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C1707251
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
UMLS CUI [6,4]
C0449238
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0030705
UMLS CUI [7,3]
C1880198
7. participant is pregnant or lactating.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. participant with sensory peripheral neuropathy of ≥ grade 2 at baseline, unable to swallow medication, or participants with prior history of seizure within the prior 12 months.
Beskrivning

Peripheral sensory neuropathy CTCAE Grades | Lacking Able to swallow Pharmaceutical Preparations | Seizure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151313
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C2712086
UMLS CUI [2,3]
C0013227
UMLS CUI [3]
C0036572
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Similar models

Eligibility Non-small Cell Lung Cancer Stage III NCT02412371

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
1. participants with histologically or cytologically confirmed stage iii non-small cell lung cancer (nsclc).
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Measurable Disease
Item
2. participants in the randomized portion of the study must have measurable disease per response evaluation criteria in solid tumors (recist), version 1.1 criteria.
boolean
C1513041 (UMLS CUI [1])
Tumor Volume | Lung Volume Measurement Suitable Therapeutic radiology procedure
Item
3. participants must have tumor volume of ≤ 150 cm^3 and v20 (volume of lung to receive 20 gy radiotherapy according to simulation) < 35%.
boolean
C0475276 (UMLS CUI [1])
C0024129 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
ECOG performance status
Item
4. participant must have an eastern cooperative oncology group (ecog) performance score of 0 - 1.
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Pulmonary function
Item
5. participant must have adequate hematologic, renal, hepatic, and lung function.
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0231921 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Prior Chemotherapy Non-Small Cell Lung Carcinoma | Prior radiation therapy Non-Small Cell Lung Carcinoma
Item
1. participants with prior chemotherapy or radiotherapy (rt) for current nsclc. participants curatively treated for past early stage nsclc greater than 3 years ago may be included.
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
Exposure to Poly(ADP-ribose) Polymerase Inhibitors
Item
2. participants with prior exposure to poly-adp-ribose polymerase (parp) inhibitors.
boolean
C0332157 (UMLS CUI [1,1])
C1882413 (UMLS CUI [1,2])
Carboplatin allergy | Paclitaxel allergy | Hypersensitivity POLYOXYETHYLATED CASTOR OIL | Hypersensitivity Cremophor
Item
3. participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (cremophor).
boolean
C0570701 (UMLS CUI [1])
C0570707 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0982061 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0056475 (UMLS CUI [4,2])
Radiotherapy to mediastinum | Radiotherapy to thorax
Item
4. participants with prior mediastinal or thoracic radiotherapy. prior tangential rt to prior breast cancer is acceptable.
boolean
C4049191 (UMLS CUI [1])
C4038705 (UMLS CUI [2])
Major surgery | Exception Video-Assisted Thoracic Surgery | Exception Mediastinoscopy
Item
5. participants with major surgery in the 4 weeks prior to randomization (video-assisted thoracoscopic surgery (vats) and/or mediastinoscopy is not considered major surgery).
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0752151 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0025065 (UMLS CUI [3,2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Curative treatment Cancer Other | Exception Disease Free Duration | Exception Patient Cured
Item
6. participants with a previous or concurrent malignancy except for treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient received potentially curative treatment and has been disease-free for 3 years or is considered cured by the investigator if has been disease-free for less than 3 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
C1705847 (UMLS CUI [7,1])
C0030705 (UMLS CUI [7,2])
C1880198 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
7. participant is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Peripheral sensory neuropathy CTCAE Grades | Lacking Able to swallow Pharmaceutical Preparations | Seizure
Item
8. participant with sensory peripheral neuropathy of ≥ grade 2 at baseline, unable to swallow medication, or participants with prior history of seizure within the prior 12 months.
boolean
C0151313 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0332268 (UMLS CUI [2,1])
C2712086 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C0036572 (UMLS CUI [3])
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