ID

36286

Beschreibung

Proton Beam Radiation Therapy in Treating Patients With Recurrent Thoracic Cancer Who Have Received Prior Radiation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02204761

Link

https://clinicaltrials.gov/show/NCT02204761

Stichworte

Versionen (1)
  1. 29.04.19 29.04.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

29. April 2019

DOI

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Creative Commons BY 4.0
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Eligibility Lung Metastases NCT02204761

Englisch

Eligibility Lung Metastases NCT02204761

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
women of child-bearing age must have a negative pregnancy test
Beschreibung

Childbearing Potential Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
patients must have received prior radiation treatment to the chest; records of prior radiation treatment must be available
Beschreibung

Radiotherapy to thorax | Medical Records Prior radiation therapy Available

Datentyp

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2,1]
C0025102
UMLS CUI [2,2]
C0279134
UMLS CUI [2,3]
C0470187
patients must have received prior chest radiation at least 3 months prior to enrollment in this trial; radiation treatment to other body sites not overlapping with current radiation fields are allowed within the 3 months period (example, brain radiation is allowed)
Beschreibung

Radiotherapy to thorax | Therapeutic radiology procedure Body site Other | Radiotherapy to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C4038705
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1545955
UMLS CUI [2,3]
C0205394
UMLS CUI [3]
C0948319
patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography [ct] scans at least 6 weeks apart, with either a > 25% or > 5 mm increase in longest dimension)
Beschreibung

Prior diagnosis Carcinoma Thoracic cavity | Carcinoma of lung | Metastatic Lesion | Secondary malignant neoplasm of female breast | Colorectal Carcinoma Spreading Lung | Thoracic Neoplasm Recurrent | Chest mass Enlarging CT scan Quantity | Longest Diameter Increase

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0007097
UMLS CUI [1,3]
C0230139
UMLS CUI [2]
C0684249
UMLS CUI [3]
C1513183
UMLS CUI [4]
C0346993
UMLS CUI [5,1]
C0009402
UMLS CUI [5,2]
C0332261
UMLS CUI [5,3]
C0024109
UMLS CUI [6,1]
C0039981
UMLS CUI [6,2]
C2945760
UMLS CUI [7,1]
C0347941
UMLS CUI [7,2]
C0442800
UMLS CUI [7,3]
C0040405
UMLS CUI [7,4]
C1265611
UMLS CUI [8,1]
C0552406
UMLS CUI [8,2]
C0442805
patients must have a life expectancy of > 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on ct imaging)
Beschreibung

Proton Therapy Possible Measurable Disease | Tumor size Minimum CT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0436226
UMLS CUI [1,2]
C0332149
UMLS CUI [1,3]
C1513041
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C1524031
UMLS CUI [2,3]
C0040405
patients should have either non-metastatic cancer of the thorax, or metastatic cancer to the thorax and candidate for definitive radiation dose to the thoracic tumor (not palliative intent), tumor radiation dose to at least bed2gy 60 gy
Beschreibung

Thoracic Neoplasm | Neoplasm Metastasis Spreading Chest | Radiation dose Thoracic Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C0039981
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332261
UMLS CUI [2,3]
C0817096
UMLS CUI [3,1]
C4019308
UMLS CUI [3,2]
C0039981
patients must be able to receive proton radiation treatment
Beschreibung

Proton Therapy Receive Able

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0436226
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0085732
all stages of cancer are eligible
Beschreibung

Malignant Neoplasms TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3258246
there are no limits on prior therapy; patients are allowed to have prior chemotherapy and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy or surgery after radiation treatment
Beschreibung

Prior Chemotherapy | Operative Surgical Procedures Previous | Therapeutic radiology procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205156
UMLS CUI [3]
C1522449
patients are allowed to be on another study concurrent with this protocol
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
ability to understand and the willingness to sign a written informed consent document
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have never received radiation to the chest
Beschreibung

Radiotherapy to thorax Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0332197
patients who received radiation to the chest within the past 3 months (in a region that overlaps with current radiation fields)
Beschreibung

Radiotherapy to thorax Recent | Overlapping Radiation Field Current

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0185027
UMLS CUI [2,2]
C1882536
UMLS CUI [2,3]
C0521116
patients with life expectancy < 6 months
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
pregnant women
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
patients unable to provide informed consent
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
prisoners
Beschreibung

Prisoners

Datentyp

boolean

Alias
UMLS CUI [1]
C0033167
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Ähnliche Modelle

Eligibility Lung Metastases NCT02204761

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Childbearing Potential Pregnancy test negative
Item
women of child-bearing age must have a negative pregnancy test
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Radiotherapy to thorax | Medical Records Prior radiation therapy Available
Item
patients must have received prior radiation treatment to the chest; records of prior radiation treatment must be available
boolean
C4038705 (UMLS CUI [1])
C0025102 (UMLS CUI [2,1])
C0279134 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
Radiotherapy to thorax | Therapeutic radiology procedure Body site Other | Radiotherapy to brain
Item
patients must have received prior chest radiation at least 3 months prior to enrollment in this trial; radiation treatment to other body sites not overlapping with current radiation fields are allowed within the 3 months period (example, brain radiation is allowed)
boolean
C4038705 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C1545955 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C0948319 (UMLS CUI [3])
Prior diagnosis Carcinoma Thoracic cavity | Carcinoma of lung | Metastatic Lesion | Secondary malignant neoplasm of female breast | Colorectal Carcinoma Spreading Lung | Thoracic Neoplasm Recurrent | Chest mass Enlarging CT scan Quantity | Longest Diameter Increase
Item
patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography [ct] scans at least 6 weeks apart, with either a > 25% or > 5 mm increase in longest dimension)
boolean
C0332132 (UMLS CUI [1,1])
C0007097 (UMLS CUI [1,2])
C0230139 (UMLS CUI [1,3])
C0684249 (UMLS CUI [2])
C1513183 (UMLS CUI [3])
C0346993 (UMLS CUI [4])
C0009402 (UMLS CUI [5,1])
C0332261 (UMLS CUI [5,2])
C0024109 (UMLS CUI [5,3])
C0039981 (UMLS CUI [6,1])
C2945760 (UMLS CUI [6,2])
C0347941 (UMLS CUI [7,1])
C0442800 (UMLS CUI [7,2])
C0040405 (UMLS CUI [7,3])
C1265611 (UMLS CUI [7,4])
C0552406 (UMLS CUI [8,1])
C0442805 (UMLS CUI [8,2])
Life Expectancy
Item
patients must have a life expectancy of > 6 months
boolean
C0023671 (UMLS CUI [1])
Proton Therapy Possible Measurable Disease | Tumor size Minimum CT
Item
patients must have measurable disease to be treated with proton radiation (minimum tumor dimension at least 10 mm on ct imaging)
boolean
C0436226 (UMLS CUI [1,1])
C0332149 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C0475440 (UMLS CUI [2,1])
C1524031 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
Thoracic Neoplasm | Neoplasm Metastasis Spreading Chest | Radiation dose Thoracic Neoplasm
Item
patients should have either non-metastatic cancer of the thorax, or metastatic cancer to the thorax and candidate for definitive radiation dose to the thoracic tumor (not palliative intent), tumor radiation dose to at least bed2gy 60 gy
boolean
C0039981 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0332261 (UMLS CUI [2,2])
C0817096 (UMLS CUI [2,3])
C4019308 (UMLS CUI [3,1])
C0039981 (UMLS CUI [3,2])
Proton Therapy Receive Able
Item
patients must be able to receive proton radiation treatment
boolean
C0436226 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Malignant Neoplasms TNM clinical staging
Item
all stages of cancer are eligible
boolean
C0006826 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Prior Chemotherapy | Operative Surgical Procedures Previous | Therapeutic radiology procedure
Item
there are no limits on prior therapy; patients are allowed to have prior chemotherapy and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy or surgery after radiation treatment
boolean
C1514457 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3])
Study Subject Participation Status
Item
patients are allowed to be on another study concurrent with this protocol
boolean
C2348568 (UMLS CUI [1])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Radiotherapy to thorax Absent
Item
patients who have never received radiation to the chest
boolean
C4038705 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Radiotherapy to thorax Recent | Overlapping Radiation Field Current
Item
patients who received radiation to the chest within the past 3 months (in a region that overlaps with current radiation fields)
boolean
C4038705 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0185027 (UMLS CUI [2,1])
C1882536 (UMLS CUI [2,2])
C0521116 (UMLS CUI [2,3])
Life Expectancy
Item
patients with life expectancy < 6 months
boolean
C0023671 (UMLS CUI [1])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Informed Consent Unable
Item
patients unable to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Prisoners
Item
prisoners
boolean
C0033167 (UMLS CUI [1])
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