ID

37436

Description

Photodynamic Therapy During Surgery in Treating Patients With Pleural Malignancy; ODM derived from: https://clinicaltrials.gov/show/NCT02106559

Link

https://clinicaltrials.gov/show/NCT02106559

Keywords

Versions (1)
  1. 7/26/19 7/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Stage III Malignant Mesothelioma NCT02106559

English

Eligibility Stage III Malignant Mesothelioma NCT02106559

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological diagnosis of nsclc or mpm; pts must have clinical and/or pathological evidence of pleural spread or stage iii/iv mpm
Description

Non-Small Cell Lung Carcinoma | Malignant Pleural Mesothelioma | Spread Pleural | Malignant Pleural Mesothelioma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0812413
UMLS CUI [3,1]
C0332261
UMLS CUI [3,2]
C1522720
UMLS CUI [4,1]
C0812413
UMLS CUI [4,2]
C3258246
pts with nsclc who have received, are receiving or are planning to receive two to four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not be permitted during the active study period; post-operative radiotherapy can be administered as clinically indicated
Description

Non-Small Cell Lung Carcinoma | Chemotherapy cycle Quantity | Chemotherapy cycle Quantity Planned | Postoperative course of radiotherapy Possible

Data type

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C1302181
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1302181
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1301732
UMLS CUI [4,1]
C0436206
UMLS CUI [4,2]
C0332149
assessment by the attending thoracic surgeon that the primary tumor is resectable in pts with nsclc and pleural spread; tumor will be deemed resectable if there is no extension through fascia, no bony chest or vertebral body involvement, and no radiographic evidence of mediastinal involvement
Description

Primary tumor Resectable | Non-Small Cell Lung Carcinoma | Spread Pleural | Extension Fascia Absent | Absence Involvement Chest Bony | Involvement Body of vertebra Absent | Involvement Mediastinal Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1514888
UMLS CUI [2]
C0007131
UMLS CUI [3,1]
C0332261
UMLS CUI [3,2]
C1522720
UMLS CUI [4,1]
C0231448
UMLS CUI [4,2]
C0015641
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C1314939
UMLS CUI [5,3]
C0817096
UMLS CUI [5,4]
C0443157
UMLS CUI [6,1]
C1314939
UMLS CUI [6,2]
C0223084
UMLS CUI [6,3]
C0332197
UMLS CUI [7,1]
C1314939
UMLS CUI [7,2]
C1522718
UMLS CUI [7,3]
C0332197
assessment by the attending thoracic surgeon that radical pleurectomy can be safely achieved in pts with malignant pleural mesothelioma
Description

Malignant Pleural Mesothelioma | Pleurectomy Radical Possible

Data type

boolean

Alias
UMLS CUI [1]
C0812413
UMLS CUI [2,1]
C0152463
UMLS CUI [2,2]
C0439807
UMLS CUI [2,3]
C0332149
all studies required for evaluation will be performed within 8 weeks of photofrin administration
Description

Study Evaluation Performed | Photofrin Administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C1261322
UMLS CUI [1,3]
C0884358
UMLS CUI [2,1]
C0729236
UMLS CUI [2,2]
C1533734
pts of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, then appropriate measures will be undertaken to attempt to increase participation of pts of that minority or gender group
Description

Ethnic group All | Gender | Minority Groups

Data type

boolean

Alias
UMLS CUI [1,1]
C0015031
UMLS CUI [1,2]
C0444868
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0026192
eligibility criteria for historical control population
Description

Eligibility Criteria Control Group

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0009932
pts undergoing extrapleural pneumonectomy without pdt for mpm or stage iv (m1a) nsclc (after american joint committee on cancer [ajcc] staging change 2010) or stage iiib (before staging change) with malignant pleural effusion treated at ohio state university (osu) from 2005-2012
Description

Extrapleural pneumonectomy | Absence Photochemotherapy Malignant Pleural Mesothelioma | Absence Photochemotherapy Non-Small Cell Lung Carcinoma TNM clinical staging | Malignant Pleural Effusion Treated

Data type

boolean

Alias
UMLS CUI [1]
C0396583
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0031740
UMLS CUI [2,3]
C0812413
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0031740
UMLS CUI [3,3]
C0007131
UMLS CUI [3,4]
C3258246
UMLS CUI [4,1]
C0080032
UMLS CUI [4,2]
C1522326
historical control data will be derived from patient medical records at the ohio state university medical center (osumc)
Description

Control Data Medical Records

Data type

boolean

Alias
UMLS CUI [1,1]
C0243148
UMLS CUI [1,2]
C1511726
UMLS CUI [1,3]
C0025102
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pts who have grade iii-iv elevations in liver transaminases (as defined by the common terminology criteria for adverse events [ctcae] version [v.] 4.0) or a bilirubin in excess of 1.5 mg/dl
Description

Elevated hepatic transaminases CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C1848701
UMLS CUI [1,2]
C1516728
pts who are medically unfit to tolerate surgery
Description

Patients Medically unfit Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C0543467
pts with known human immunodeficiency virus (hiv) or hepatitis c virus (hcv) disease (routine testing is not needed if not clinical indicated)
Description

HIV Infection | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019196
pregnant or lactating pts
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior treatment for nsclc except for pleurodesis and/or standard frontline chemotherapy
Description

Prior Therapy Non-Small Cell Lung Carcinoma | Exception Pleurodesis | Exception Standard Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0007131
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0189557
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1442989
UMLS CUI [3,3]
C0392920
pts who have received prior mantle or extensive mediastinal radiation
Description

Mantle field irradiation | Irradiation of mediastinum Extensive

Data type

boolean

Alias
UMLS CUI [1]
C1168306
UMLS CUI [2,1]
C2152905
UMLS CUI [2,2]
C0205231
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Similar models

Eligibility Stage III Malignant Mesothelioma NCT02106559

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Malignant Pleural Mesothelioma | Spread Pleural | Malignant Pleural Mesothelioma TNM clinical staging
Item
histological diagnosis of nsclc or mpm; pts must have clinical and/or pathological evidence of pleural spread or stage iii/iv mpm
boolean
C0007131 (UMLS CUI [1])
C0812413 (UMLS CUI [2])
C0332261 (UMLS CUI [3,1])
C1522720 (UMLS CUI [3,2])
C0812413 (UMLS CUI [4,1])
C3258246 (UMLS CUI [4,2])
Non-Small Cell Lung Carcinoma | Chemotherapy cycle Quantity | Chemotherapy cycle Quantity Planned | Postoperative course of radiotherapy Possible
Item
pts with nsclc who have received, are receiving or are planning to receive two to four cycles of standard frontline chemotherapy are eligible; choice of chemotherapy is at the discretion of the medical oncologist; concurrent chemoradiotherapy will not be permitted during the active study period; post-operative radiotherapy can be administered as clinically indicated
boolean
C0007131 (UMLS CUI [1])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1302181 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1301732 (UMLS CUI [3,3])
C0436206 (UMLS CUI [4,1])
C0332149 (UMLS CUI [4,2])
Primary tumor Resectable | Non-Small Cell Lung Carcinoma | Spread Pleural | Extension Fascia Absent | Absence Involvement Chest Bony | Involvement Body of vertebra Absent | Involvement Mediastinal Absent
Item
assessment by the attending thoracic surgeon that the primary tumor is resectable in pts with nsclc and pleural spread; tumor will be deemed resectable if there is no extension through fascia, no bony chest or vertebral body involvement, and no radiographic evidence of mediastinal involvement
boolean
C0677930 (UMLS CUI [1,1])
C1514888 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2])
C0332261 (UMLS CUI [3,1])
C1522720 (UMLS CUI [3,2])
C0231448 (UMLS CUI [4,1])
C0015641 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0817096 (UMLS CUI [5,3])
C0443157 (UMLS CUI [5,4])
C1314939 (UMLS CUI [6,1])
C0223084 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C1314939 (UMLS CUI [7,1])
C1522718 (UMLS CUI [7,2])
C0332197 (UMLS CUI [7,3])
Malignant Pleural Mesothelioma | Pleurectomy Radical Possible
Item
assessment by the attending thoracic surgeon that radical pleurectomy can be safely achieved in pts with malignant pleural mesothelioma
boolean
C0812413 (UMLS CUI [1])
C0152463 (UMLS CUI [2,1])
C0439807 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
Study Evaluation Performed | Photofrin Administration
Item
all studies required for evaluation will be performed within 8 weeks of photofrin administration
boolean
C0008972 (UMLS CUI [1,1])
C1261322 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C0729236 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
Ethnic group All | Gender | Minority Groups
Item
pts of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, then appropriate measures will be undertaken to attempt to increase participation of pts of that minority or gender group
boolean
C0015031 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2])
C0026192 (UMLS CUI [3])
Eligibility Criteria Control Group
Item
eligibility criteria for historical control population
boolean
C1516637 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Extrapleural pneumonectomy | Absence Photochemotherapy Malignant Pleural Mesothelioma | Absence Photochemotherapy Non-Small Cell Lung Carcinoma TNM clinical staging | Malignant Pleural Effusion Treated
Item
pts undergoing extrapleural pneumonectomy without pdt for mpm or stage iv (m1a) nsclc (after american joint committee on cancer [ajcc] staging change 2010) or stage iiib (before staging change) with malignant pleural effusion treated at ohio state university (osu) from 2005-2012
boolean
C0396583 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0031740 (UMLS CUI [2,2])
C0812413 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0031740 (UMLS CUI [3,2])
C0007131 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
C0080032 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
Control Data Medical Records
Item
historical control data will be derived from patient medical records at the ohio state university medical center (osumc)
boolean
C0243148 (UMLS CUI [1,1])
C1511726 (UMLS CUI [1,2])
C0025102 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Elevated hepatic transaminases CTCAE Grades
Item
pts who have grade iii-iv elevations in liver transaminases (as defined by the common terminology criteria for adverse events [ctcae] version [v.] 4.0) or a bilirubin in excess of 1.5 mg/dl
boolean
C1848701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Patients Medically unfit Operative Surgical Procedures
Item
pts who are medically unfit to tolerate surgery
boolean
C0030705 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
HIV Infection | Hepatitis C
Item
pts with known human immunodeficiency virus (hiv) or hepatitis c virus (hcv) disease (routine testing is not needed if not clinical indicated)
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating pts
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Therapy Non-Small Cell Lung Carcinoma | Exception Pleurodesis | Exception Standard Chemotherapy
Item
prior treatment for nsclc except for pleurodesis and/or standard frontline chemotherapy
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0189557 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1442989 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
Mantle field irradiation | Irradiation of mediastinum Extensive
Item
pts who have received prior mantle or extensive mediastinal radiation
boolean
C1168306 (UMLS CUI [1])
C2152905 (UMLS CUI [2,1])
C0205231 (UMLS CUI [2,2])
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