ID

36651

Beskrivning

Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02417662

Länk

https://clinicaltrials.gov/show/NCT02417662

Nyckelord

Versioner (1)
  1. 2019-05-28 2019-05-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT02417662

Engelsk

Eligibility Non-small Cell Lung Cancer NCT02417662

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed nsclc
Beskrivning

Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
2. negative or unknown egfr, alk, ros1 mutation status (testing not mandatory)
Beskrivning

EGFR gene mutation Negative | EGFR gene mutation Status Unknown | ALK gene mutation Negative | ALK gene mutation Status Unknown | ROS1 Gene Mutation Negative | ROS1 Gene Mutation Status Unknown

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1513916
UMLS CUI [2,1]
C3266992
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0439673
UMLS CUI [3,1]
C2825843
UMLS CUI [3,2]
C1513916
UMLS CUI [4,1]
C2825843
UMLS CUI [4,2]
C0449438
UMLS CUI [4,3]
C0439673
UMLS CUI [5,1]
C4331213
UMLS CUI [5,2]
C1513916
UMLS CUI [6,1]
C4331213
UMLS CUI [6,2]
C0449438
UMLS CUI [6,3]
C0439673
3. patient has been staged with fdg pet-ct whole body scan and brain mri. scans to be performed within 42 days of registration.
Beskrivning

Patient Staged FDG-PET/CT of the Whole Body | Patient Staged MRI brain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3846398
UMLS CUI [1,3]
C4527276
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C3846398
UMLS CUI [2,3]
C0412675
4. patient is fit to receive at least four cycles of platinum-based doublet chemotherapy, cisplatin or carboplatin, according to local guidelines and assessment
Beskrivning

Chemotherapy cycle Quantity | Chemotherapy Platinum-Based Double | Cisplatin | Carboplatin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1302181
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1514162
UMLS CUI [2,3]
C0205173
UMLS CUI [3]
C0008838
UMLS CUI [4]
C0079083
5. primary tumour amenable to radical rt (either conventional fractionation or srt) i) nodes included in the radical rt volume will not count towards the number of sites of metastases ii) conventional rt fields do not need to be contiguous. iii) nodes not treated in the radical rt volume are counted as metastases. the same rt dose constraint eligibility criteria will apply to these nodes as to other metastases.
Beskrivning

Primary tumor Amenable Therapeutic radiology procedure Radical | Radiotherapy fractionation conventional | Radiotherapy, Stereotactic | Lymph node involvement | Radiation Field conventional | Secondary malignant neoplasm of lymph node

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C3900053
UMLS CUI [1,3]
C1522449
UMLS CUI [1,4]
C0439807
UMLS CUI [2,1]
C3161031
UMLS CUI [2,2]
C0439858
UMLS CUI [3]
C3846112
UMLS CUI [4]
C0806692
UMLS CUI [5,1]
C1882536
UMLS CUI [5,2]
C0439858
UMLS CUI [6]
C0686619
iv) considering neck nodes, only station 1 nodes (foundation system) are considered n3. higher neck nodes are considered as metastases.
Beskrivning

Cervical lymph nodes TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0588054
UMLS CUI [1,2]
C3258246
6. acceptable lung function in accordance with local guidelines
Beskrivning

Pulmonary function

Datatyp

boolean

Alias
UMLS CUI [1]
C0231921
7. between one and three sites of metastatic disease i) each individual involved lymph node outside of the radical rt volume will count as 1 site, even within the same nodal region ii) this must include at least one site of extra-cranial disease.
Beskrivning

Neoplasm Metastasis Site Quantity | Lymph Node Involvement | Disease Extracranial Site Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0806692
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0580586
UMLS CUI [3,3]
C1515974
UMLS CUI [3,4]
C1265611
8. all sites of metastatic disease suitable for srt
Beskrivning

Neoplasm Metastasis | Sites suitable Stereotactic Radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C3900053
UMLS CUI [2,3]
C3846112
9. no relevant co-morbidities, including pulmonary fibrosis, connective tissue disorders.
Beskrivning

Comorbidity Absent | Pulmonary Fibrosis Absent | Connective Tissue Diseases Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0034069
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0009782
UMLS CUI [3,2]
C0332197
10. ecog performance status 0 to 1 at time of registration
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
11. for bone metastases, pre-srt stabilisation should be considered as clinically appropriate.
Beskrivning

Secondary malignant neoplasm of bone | Stabilization Before Stereotactic Radiotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0153690
UMLS CUI [2,1]
C1293130
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C3846112
12. patients with up to 3 metastases at the time of registration but less than 3 are visible after systemic therapy are still eligible for randomisation.
Beskrivning

Neoplasm Metastasis Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1265611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient requires palliative radiotherapy to any tumour site before the start of chemotherapy
Beskrivning

Palliative course of radiotherapy Tumor site

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0475092
UMLS CUI [1,2]
C0475445
2. patients who present with brain metastasis only and no other sites of extra cranial disease, as evidenced by a mri of the brain no more than 42 days prior to registration
Beskrivning

Metastatic malignant neoplasm to brain MRI brain | Disease Extracranial Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0412675
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0580586
UMLS CUI [2,3]
C0332197
3. metastasis in sites where normal constraints cannot be met.
Beskrivning

Neoplasm Metastasis Site | Site Free of Constraint Normal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C0443288
UMLS CUI [2,4]
C0205307
4. metastasis in a previously irradiated area
Beskrivning

Neoplasm Metastasis Body Region Prior radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0005898
UMLS CUI [1,3]
C0279134
5. patients who had more than three sites of disease prior to systemic therapy even if some are no longer visible or have been ablated surgically or by other means.
Beskrivning

Disease Site Quantity | Status pre- Systemic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C1515119
6. primary tumour or metastases causing involvement of major blood vessels
Beskrivning

Primary tumor Involving Blood Vessels Major | Neoplasm Metastasis Involving Blood Vessels Major

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0005847
UMLS CUI [1,4]
C0205164
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0005847
UMLS CUI [2,4]
C0205164
7. malignant pleural or pericardial effusion
Beskrivning

Pleural Effusion, Malignant | Malignant pericardial effusion

Datatyp

boolean

Alias
UMLS CUI [1]
C0080032
UMLS CUI [2]
C0220655
8. patients with bilateral adrenal metastases
Beskrivning

Metastases to adrenals Bilateral

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0854178
UMLS CUI [1,2]
C0238767
9. one or more metastases treated with alternative ablative treatment, e.g. rfa or surgery
Beskrivning

Ablation therapy Neoplasm Metastasis Quantity | Radiofrequency ablation | Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0850292
UMLS CUI [3]
C0543467
10. women who are pregnant or lactating
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Non-small Cell Lung Cancer NCT02417662

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. histologically or cytologically confirmed nsclc
boolean
C0007131 (UMLS CUI [1])
EGFR gene mutation Negative | EGFR gene mutation Status Unknown | ALK gene mutation Negative | ALK gene mutation Status Unknown | ROS1 Gene Mutation Negative | ROS1 Gene Mutation Status Unknown
Item
2. negative or unknown egfr, alk, ros1 mutation status (testing not mandatory)
boolean
C3266992 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C3266992 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0439673 (UMLS CUI [2,3])
C2825843 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C2825843 (UMLS CUI [4,1])
C0449438 (UMLS CUI [4,2])
C0439673 (UMLS CUI [4,3])
C4331213 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C4331213 (UMLS CUI [6,1])
C0449438 (UMLS CUI [6,2])
C0439673 (UMLS CUI [6,3])
Patient Staged FDG-PET/CT of the Whole Body | Patient Staged MRI brain
Item
3. patient has been staged with fdg pet-ct whole body scan and brain mri. scans to be performed within 42 days of registration.
boolean
C0030705 (UMLS CUI [1,1])
C3846398 (UMLS CUI [1,2])
C4527276 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C3846398 (UMLS CUI [2,2])
C0412675 (UMLS CUI [2,3])
Chemotherapy cycle Quantity | Chemotherapy Platinum-Based Double | Cisplatin | Carboplatin
Item
4. patient is fit to receive at least four cycles of platinum-based doublet chemotherapy, cisplatin or carboplatin, according to local guidelines and assessment
boolean
C1302181 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
C0205173 (UMLS CUI [2,3])
C0008838 (UMLS CUI [3])
C0079083 (UMLS CUI [4])
Primary tumor Amenable Therapeutic radiology procedure Radical | Radiotherapy fractionation conventional | Radiotherapy, Stereotactic | Lymph node involvement | Radiation Field conventional | Secondary malignant neoplasm of lymph node
Item
5. primary tumour amenable to radical rt (either conventional fractionation or srt) i) nodes included in the radical rt volume will not count towards the number of sites of metastases ii) conventional rt fields do not need to be contiguous. iii) nodes not treated in the radical rt volume are counted as metastases. the same rt dose constraint eligibility criteria will apply to these nodes as to other metastases.
boolean
C0677930 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C0439807 (UMLS CUI [1,4])
C3161031 (UMLS CUI [2,1])
C0439858 (UMLS CUI [2,2])
C3846112 (UMLS CUI [3])
C0806692 (UMLS CUI [4])
C1882536 (UMLS CUI [5,1])
C0439858 (UMLS CUI [5,2])
C0686619 (UMLS CUI [6])
Cervical lymph nodes TNM clinical staging
Item
iv) considering neck nodes, only station 1 nodes (foundation system) are considered n3. higher neck nodes are considered as metastases.
boolean
C0588054 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Pulmonary function
Item
6. acceptable lung function in accordance with local guidelines
boolean
C0231921 (UMLS CUI [1])
Neoplasm Metastasis Site Quantity | Lymph Node Involvement | Disease Extracranial Site Quantity
Item
7. between one and three sites of metastatic disease i) each individual involved lymph node outside of the radical rt volume will count as 1 site, even within the same nodal region ii) this must include at least one site of extra-cranial disease.
boolean
C0027627 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0806692 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0580586 (UMLS CUI [3,2])
C1515974 (UMLS CUI [3,3])
C1265611 (UMLS CUI [3,4])
Neoplasm Metastasis | Sites suitable Stereotactic Radiotherapy
Item
8. all sites of metastatic disease suitable for srt
boolean
C0027627 (UMLS CUI [1])
C1515974 (UMLS CUI [2,1])
C3900053 (UMLS CUI [2,2])
C3846112 (UMLS CUI [2,3])
Comorbidity Absent | Pulmonary Fibrosis Absent | Connective Tissue Diseases Absent
Item
9. no relevant co-morbidities, including pulmonary fibrosis, connective tissue disorders.
boolean
C0009488 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0009782 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
ECOG performance status
Item
10. ecog performance status 0 to 1 at time of registration
boolean
C1520224 (UMLS CUI [1])
Secondary malignant neoplasm of bone | Stabilization Before Stereotactic Radiotherapy
Item
11. for bone metastases, pre-srt stabilisation should be considered as clinically appropriate.
boolean
C0153690 (UMLS CUI [1])
C1293130 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C3846112 (UMLS CUI [2,3])
Neoplasm Metastasis Quantity
Item
12. patients with up to 3 metastases at the time of registration but less than 3 are visible after systemic therapy are still eligible for randomisation.
boolean
C0027627 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Palliative course of radiotherapy Tumor site
Item
1. patient requires palliative radiotherapy to any tumour site before the start of chemotherapy
boolean
C0475092 (UMLS CUI [1,1])
C0475445 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain MRI brain | Disease Extracranial Absent
Item
2. patients who present with brain metastasis only and no other sites of extra cranial disease, as evidenced by a mri of the brain no more than 42 days prior to registration
boolean
C0220650 (UMLS CUI [1,1])
C0412675 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0580586 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Neoplasm Metastasis Site | Site Free of Constraint Normal
Item
3. metastasis in sites where normal constraints cannot be met.
boolean
C0027627 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0443288 (UMLS CUI [2,3])
C0205307 (UMLS CUI [2,4])
Neoplasm Metastasis Body Region Prior radiation therapy
Item
4. metastasis in a previously irradiated area
boolean
C0027627 (UMLS CUI [1,1])
C0005898 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
Disease Site Quantity | Status pre- Systemic therapy
Item
5. patients who had more than three sites of disease prior to systemic therapy even if some are no longer visible or have been ablated surgically or by other means.
boolean
C0012634 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332152 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
Primary tumor Involving Blood Vessels Major | Neoplasm Metastasis Involving Blood Vessels Major
Item
6. primary tumour or metastases causing involvement of major blood vessels
boolean
C0677930 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C0205164 (UMLS CUI [1,4])
C0027627 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0005847 (UMLS CUI [2,3])
C0205164 (UMLS CUI [2,4])
Pleural Effusion, Malignant | Malignant pericardial effusion
Item
7. malignant pleural or pericardial effusion
boolean
C0080032 (UMLS CUI [1])
C0220655 (UMLS CUI [2])
Metastases to adrenals Bilateral
Item
8. patients with bilateral adrenal metastases
boolean
C0854178 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Ablation therapy Neoplasm Metastasis Quantity | Radiofrequency ablation | Operative Surgical Procedures
Item
9. one or more metastases treated with alternative ablative treatment, e.g. rfa or surgery
boolean
C0547070 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0850292 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
10. women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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