ID

30274

Beschrijving

Stereotactic Body Radiation Therapy in Stage II/III Non Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01657617

Link

https://clinicaltrials.gov/show/NCT01657617

Trefwoorden

Versies (1)
  1. 26-05-18 26-05-18 -
Houder van rechten

See clinicaltrials.gov

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26 mei 2018

DOI

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Creative Commons BY 4.0
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Eligibility Lung Cancer NCT01657617

Engels

Eligibility Lung Cancer NCT01657617

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological confirmation of non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchoalveolar cell carcinoma, or non-small cell carcinoma nos) by either biopsy or cytology.
Beschrijving

Non-Small Cell Lung Carcinoma | Squamous cell carcinoma | Adenocarcinoma | Carcinoma, Large Cell | Bronchioloalveolar Adenocarcinoma | Non-small cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2]
C0007137
UMLS CUI [3]
C0001418
UMLS CUI [4]
C0206704
UMLS CUI [5]
C0007120
UMLS CUI [6]
C1266002
2. clinical ajcc stage iia (t1n1m0), iib (t2,n1m0, t3,n0,m0) or iiia (t1-3, n1-2,m0)/selected iiib. in all cases, patients may be included at the discretion of the treating radiation oncologist if it will be likely the disease can be encompassed by the stereotactic boost will be included.
Beschrijving

TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1]
C3258246
3. patients with non-bulky (< 2.0-3.0 cm) hilar or mediastinal lymphadenopathy determined by pre-treatment ct scan, pet or mediastinoscopy
Beschrijving

Hilar lymphadenopathy Size CT scan pre treatment | Mediastinal lymphadenopathy Size CT scan pre treatment | Hilar lymphadenopathy Size PET pre treatment | Mediastinal lymphadenopathy Size PET pre treatment | Hilar lymphadenopathy Size Mediastinoscopy pre treatment | Mediastinal lymphadenopathy Size Mediastinoscopy pre treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0456973
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C0040405
UMLS CUI [1,4]
C2709094
UMLS CUI [2,1]
C0520743
UMLS CUI [2,2]
C0456389
UMLS CUI [2,3]
C0040405
UMLS CUI [2,4]
C2709094
UMLS CUI [3,1]
C0456973
UMLS CUI [3,2]
C0456389
UMLS CUI [3,3]
C0032743
UMLS CUI [3,4]
C2709094
UMLS CUI [4,1]
C0520743
UMLS CUI [4,2]
C0456389
UMLS CUI [4,3]
C0032743
UMLS CUI [4,4]
C2709094
UMLS CUI [5,1]
C0456973
UMLS CUI [5,2]
C0456389
UMLS CUI [5,3]
C0025065
UMLS CUI [5,4]
C2709094
UMLS CUI [6,1]
C0520743
UMLS CUI [6,2]
C0456389
UMLS CUI [6,3]
C0025065
UMLS CUI [6,4]
C2709094
4. must have completed a standard course of chemoradiation in accordance with nccn guidelines
Beschrijving

Chemoradiotherapy Standard Course Completed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0436307
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0750729
UMLS CUI [1,4]
C0205197
5. one month following definitive chemoradiation, ct or pet-ct revealing limited volume residual disease within the site of primary tumour mass (post-chemo/rt mass </= 7.0 cm). patients with a cr and no obvious target are not eligible.
Beschrijving

Status post Chemoradiotherapy | Status post CT | Status post PET-CT | Residual Tumor Volume Limited | Site Tumor Mass Primary | Tumor Mass Size Post Chemoradiotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231290
UMLS CUI [1,2]
C0436307
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0040405
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1699633
UMLS CUI [4,1]
C0543478
UMLS CUI [4,2]
C0449468
UMLS CUI [4,3]
C0439801
UMLS CUI [5,1]
C1515974
UMLS CUI [5,2]
C3273930
UMLS CUI [5,3]
C0205225
UMLS CUI [6,1]
C3273930
UMLS CUI [6,2]
C0456389
UMLS CUI [6,3]
C0687676
UMLS CUI [6,4]
C0436307
6. must be able to fit into the elekta stereotactic body frame
Beschrijving

Patient Appropriate Frame-based stereotactic device

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0582732
7. patients must be ≥ 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
8. the patient's ecog performance status must be 0-2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
9. women of childbearing potential and male participants must use an effective contraceptive method.
Beschrijving

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
10. patients must sign a study-specific consent form.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any other active cancer or no prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the patient has been disease-free for 5 years.
Beschrijving

Cancer Other | Malignant Neoplasm Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Disease Free of

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205156
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C1707251
UMLS CUI [6,3]
C0012634
UMLS CUI [6,4]
C0332296
2. patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their lung cancer prior to therapy that, in the investigators opinions, would preclude their inclusion
Beschrijving

Systemic disease | First line treatment Recovery Lacking | Carcinoma of lung Progressing

Datatype

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C2004454
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C0684249
UMLS CUI [3,2]
C0205329
3. plans for the patient to receive other concomitant antineoplastic therapy while on this protocol, except at disease progression. patients may be allowed to use bisphosphonates for hypercalcemia.
Beschrijving

Antineoplastic Agents Planned | Exception Disease Progression | Exception Diphosphonates Hypercalcemia

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0242656
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0012544
UMLS CUI [3,3]
C0020437
4. pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

Eligibility Lung Cancer NCT01657617

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma | Squamous cell carcinoma | Adenocarcinoma | Carcinoma, Large Cell | Bronchioloalveolar Adenocarcinoma | Non-small cell carcinoma
Item
1. histological confirmation of non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchoalveolar cell carcinoma, or non-small cell carcinoma nos) by either biopsy or cytology.
boolean
C0007131 (UMLS CUI [1])
C0007137 (UMLS CUI [2])
C0001418 (UMLS CUI [3])
C0206704 (UMLS CUI [4])
C0007120 (UMLS CUI [5])
C1266002 (UMLS CUI [6])
TNM clinical staging
Item
2. clinical ajcc stage iia (t1n1m0), iib (t2,n1m0, t3,n0,m0) or iiia (t1-3, n1-2,m0)/selected iiib. in all cases, patients may be included at the discretion of the treating radiation oncologist if it will be likely the disease can be encompassed by the stereotactic boost will be included.
boolean
C3258246 (UMLS CUI [1])
Hilar lymphadenopathy Size CT scan pre treatment | Mediastinal lymphadenopathy Size CT scan pre treatment | Hilar lymphadenopathy Size PET pre treatment | Mediastinal lymphadenopathy Size PET pre treatment | Hilar lymphadenopathy Size Mediastinoscopy pre treatment | Mediastinal lymphadenopathy Size Mediastinoscopy pre treatment
Item
3. patients with non-bulky (< 2.0-3.0 cm) hilar or mediastinal lymphadenopathy determined by pre-treatment ct scan, pet or mediastinoscopy
boolean
C0456973 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C2709094 (UMLS CUI [1,4])
C0520743 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C2709094 (UMLS CUI [2,4])
C0456973 (UMLS CUI [3,1])
C0456389 (UMLS CUI [3,2])
C0032743 (UMLS CUI [3,3])
C2709094 (UMLS CUI [3,4])
C0520743 (UMLS CUI [4,1])
C0456389 (UMLS CUI [4,2])
C0032743 (UMLS CUI [4,3])
C2709094 (UMLS CUI [4,4])
C0456973 (UMLS CUI [5,1])
C0456389 (UMLS CUI [5,2])
C0025065 (UMLS CUI [5,3])
C2709094 (UMLS CUI [5,4])
C0520743 (UMLS CUI [6,1])
C0456389 (UMLS CUI [6,2])
C0025065 (UMLS CUI [6,3])
C2709094 (UMLS CUI [6,4])
Chemoradiotherapy Standard Course Completed
Item
4. must have completed a standard course of chemoradiation in accordance with nccn guidelines
boolean
C0436307 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0750729 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Status post Chemoradiotherapy | Status post CT | Status post PET-CT | Residual Tumor Volume Limited | Site Tumor Mass Primary | Tumor Mass Size Post Chemoradiotherapy
Item
5. one month following definitive chemoradiation, ct or pet-ct revealing limited volume residual disease within the site of primary tumour mass (post-chemo/rt mass </= 7.0 cm). patients with a cr and no obvious target are not eligible.
boolean
C0231290 (UMLS CUI [1,1])
C0436307 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C1699633 (UMLS CUI [3,2])
C0543478 (UMLS CUI [4,1])
C0449468 (UMLS CUI [4,2])
C0439801 (UMLS CUI [4,3])
C1515974 (UMLS CUI [5,1])
C3273930 (UMLS CUI [5,2])
C0205225 (UMLS CUI [5,3])
C3273930 (UMLS CUI [6,1])
C0456389 (UMLS CUI [6,2])
C0687676 (UMLS CUI [6,3])
C0436307 (UMLS CUI [6,4])
Patient Appropriate Frame-based stereotactic device
Item
6. must be able to fit into the elekta stereotactic body frame
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0582732 (UMLS CUI [1,3])
Age
Item
7. patients must be ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
8. the patient's ecog performance status must be 0-2.
boolean
C1520224 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
9. women of childbearing potential and male participants must use an effective contraceptive method.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
10. patients must sign a study-specific consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Malignant Neoplasm Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Disease Free of
Item
1. any other active cancer or no prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer from which the patient has been disease-free for 5 years.
boolean
C1707251 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C1707251 (UMLS CUI [6,2])
C0012634 (UMLS CUI [6,3])
C0332296 (UMLS CUI [6,4])
Systemic disease | First line treatment Recovery Lacking | Carcinoma of lung Progressing
Item
2. patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their lung cancer prior to therapy that, in the investigators opinions, would preclude their inclusion
boolean
C0442893 (UMLS CUI [1])
C1708063 (UMLS CUI [2,1])
C2004454 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0684249 (UMLS CUI [3,1])
C0205329 (UMLS CUI [3,2])
Antineoplastic Agents Planned | Exception Disease Progression | Exception Diphosphonates Hypercalcemia
Item
3. plans for the patient to receive other concomitant antineoplastic therapy while on this protocol, except at disease progression. patients may be allowed to use bisphosphonates for hypercalcemia.
boolean
C0003392 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0012544 (UMLS CUI [3,2])
C0020437 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
4. pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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