ID

31089

Beskrivning

Radiation Therapy in Treating Patients With Non Small Cell Lung Cancer That Has Been Completely Removed by Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00410683

Länk

https://clinicaltrials.gov/show/NCT00410683

Nyckelord

Versioner (1)
  1. 2018-07-20 2018-07-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00410683

Engelsk

Eligibility Non-small Cell Lung Cancer NCT00410683

1 Formulär  
Criteria
Beskrivning

Criteria

1. histological evidence of non-small cell lung cancer (nsclc)
Beskrivning

Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007131
2. complete resection by lobectomy, bilobectomy or pneumonectomy (i.e patients with positive margins) or extra-capsular mediastinal nodal extension breaching the surface of the pathological specimen should not to be included
Beskrivning

Exclusion Criteria | Complete excision | Lobectomy | Bilobectomy of lung | Pneumonectomy | Positive Surgical Margins | Extra-capsular extension of nodal tumor Mediastinal

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0015250
UMLS CUI [3]
C0023928
UMLS CUI [4]
C0396580
UMLS CUI [5]
C0032284
UMLS CUI [6]
C1709603
UMLS CUI [7,1]
C1300901
UMLS CUI [7,2]
C1522718
3. mediastinal lymph node exploration (lymph node sampling or systematic dissection of lymph nodes at stations 2, 4 and 7 in case of upper/middle right-sided lung cancer; 4, 7, 8 and 9 in case of lower right-sided lung cancer; 5, 6 and 7 in case of upper left -sided lung cancer; 7, 8 and 9 in case of lower left-sided lung cancer is recommended)
Beskrivning

Mediastinal lymph node Exploration | Sampling of lymph node | Lymph Node Dissection systematic | Primary malignant neoplasm of right lung Upper | Primary malignant neoplasm of right lung Middle | Primary malignant neoplasm of right lung Lower | Primary malignant neoplasm of left lung Upper | Primary malignant neoplasm of left lung Lower

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0588055
UMLS CUI [1,2]
C1280903
UMLS CUI [2]
C0398417
UMLS CUI [3,1]
C0242382
UMLS CUI [3,2]
C0220922
UMLS CUI [4,1]
C3862551
UMLS CUI [4,2]
C1282910
UMLS CUI [5,1]
C3862551
UMLS CUI [5,2]
C0444598
UMLS CUI [6,1]
C3862551
UMLS CUI [6,2]
C0441994
UMLS CUI [7,1]
C3862552
UMLS CUI [7,2]
C1282910
UMLS CUI [8,1]
C3862552
UMLS CUI [8,2]
C0441994
4. pathologically or cytologically documented n2 mediastinal nodal involvement, at the time of surgery if no preoperative chemotherapy or before preoperative chemotherapy, according to the criteria of the joint ajcc and uicc classification, clinical n2 patients without cytological or histological documentation of mediastinal node involvement before preoperative chemotherapy can be included in the study if and only if, they have histologically confirmed n2 disease at the time of surgery
Beskrivning

TNM clinical staging | Mediastinal lymph node Involvement | Operative Surgical Procedures | Preoperative Chemotherapy Absent | Status pre- Preoperative Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0588055
UMLS CUI [2,2]
C1314939
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C2347669
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C2347669
5. prior chemotherapy is allowed (pre-operative or post-operative adjuvant chemotherapy, or both)
Beskrivning

Prior Chemotherapy | Adjuvant Chemotherapy Preoperative | Adjuvant Chemotherapy Postoperative

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C0085533
UMLS CUI [2,2]
C0445204
UMLS CUI [3,1]
C0085533
UMLS CUI [3,2]
C0032790
6. patient aged ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
7. good performance status (who ≤ 2)
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
8. fit enough to receive curative radiotherapy
Beskrivning

Fit Therapeutic radiology procedure Curative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C1522449
UMLS CUI [1,3]
C1276305
9. adequate pulmonary function with post-operative fev1 after surgery > 1 l or over 35% theoretical value
Beskrivning

Pulmonary function | FEV1 Postoperative

Datatyp

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2,1]
C0849974
UMLS CUI [2,2]
C0032790
10. signed informed consent form
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. documented metastases, (except for ipsilateral nodule(s) in a different lobe after pneumonectomy or bi-lobectomy)
Beskrivning

Neoplasm Metastasis | Exception Nodule Ipsilateral Lung lobe Different | Status post Pneumonectomy | Status post Bilobectomy of lung

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0028259
UMLS CUI [2,3]
C0441989
UMLS CUI [2,4]
C0225752
UMLS CUI [2,5]
C1705242
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0032284
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0396580
2. major pleural or pericardial effusion
Beskrivning

Pleural effusion disorder Major | Pericardial effusion Major

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032227
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0031039
UMLS CUI [2,2]
C0205164
3. synchronous contra-lateral lung cancer
Beskrivning

Malignant neoplasm of lung Contralateral Synchronous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242379
UMLS CUI [1,2]
C0441988
UMLS CUI [1,3]
C0439580
4. clinical progression during post-operative chemotherapy
Beskrivning

Disease Progression During Postoperative chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1273551
5. previous chest radiotherapy
Beskrivning

Radiotherapy to thorax

Datatyp

boolean

Alias
UMLS CUI [1]
C4038705
6. intention of concomitant chemotherapy during radiotherapy
Beskrivning

Chemotherapy During Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C1522449
7. weight loss in the previous 6 months before surgery ≥ 10 %
Beskrivning

Weight decreased Preoperative Percentage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0445204
UMLS CUI [1,3]
C0439165
8. evidence of severe or uncontrolled systemic disease as judged by the investigator
Beskrivning

Systemic disease Severe | Systemic disease Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0442893
UMLS CUI [2,2]
C0205318
9. recent (< 6 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease
Beskrivning

Heart Disease Severe | Cardiac Arrhythmia | Congestive heart failure | Infarction | Artificial cardiac pacemaker | Lung diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0021308
UMLS CUI [5]
C0030163
UMLS CUI [6]
C0024115
10. current or past history of neoplasm other than non-small cell lung cancer diagnosed within the last 5 years, except :
Beskrivning

Neoplasms | Exception Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0027651
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007131
basal cell carcinoma of the skin
Beskrivning

Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0007117
in situ carcinoma of the cervix a patient diagnosed for another neoplasm 5 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected.
Beskrivning

Carcinoma in situ of uterine cervix | Inclusion criteria Cancer Other Cured

Datatyp

boolean

Alias
UMLS CUI [1]
C0851140
UMLS CUI [2,1]
C1512693
UMLS CUI [2,2]
C1707251
UMLS CUI [2,3]
C1880198
11. pregnancy or breast feeding or inadequate contraceptive measures during treatment
Beskrivning

Pregnancy | Breast Feeding | Contraceptive methods Inadequate

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0205412
12. patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls
Beskrivning

Factor Familial Follow-up Inadequate | Social Conditions Follow-up Inadequate | Geographic Factors Follow-up Inadequate | Mental condition Follow-up Inadequate | Factor Familial Control Unsuccessful | Social Conditions Control Unsuccessful | Geographic Factors Control Unsuccessful | Mental condition Control Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0241888
UMLS CUI [1,3]
C3274571
UMLS CUI [1,4]
C0205412
UMLS CUI [2,1]
C0037403
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C0205412
UMLS CUI [3,1]
C0017444
UMLS CUI [3,2]
C3274571
UMLS CUI [3,3]
C0205412
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C3274571
UMLS CUI [4,3]
C0205412
UMLS CUI [5,1]
C1521761
UMLS CUI [5,2]
C0241888
UMLS CUI [5,3]
C0243148
UMLS CUI [5,4]
C1272705
UMLS CUI [6,1]
C0037403
UMLS CUI [6,2]
C0243148
UMLS CUI [6,3]
C1272705
UMLS CUI [7,1]
C0017444
UMLS CUI [7,2]
C0243148
UMLS CUI [7,3]
C1272705
UMLS CUI [8,1]
C3840291
UMLS CUI [8,2]
C0243148
UMLS CUI [8,3]
C1272705
13. patient deprived of freedom or under guardianship
Beskrivning

Patient Deprivation Freedom | Guardianship of Patient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0871712
UMLS CUI [1,3]
C0016694
UMLS CUI [2,1]
C0680611
UMLS CUI [2,2]
C0030705
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00410683

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Non-Small Cell Lung Carcinoma
Item
1. histological evidence of non-small cell lung cancer (nsclc)
boolean
C0007131 (UMLS CUI [1])
Exclusion Criteria | Complete excision | Lobectomy | Bilobectomy of lung | Pneumonectomy | Positive Surgical Margins | Extra-capsular extension of nodal tumor Mediastinal
Item
2. complete resection by lobectomy, bilobectomy or pneumonectomy (i.e patients with positive margins) or extra-capsular mediastinal nodal extension breaching the surface of the pathological specimen should not to be included
boolean
C0680251 (UMLS CUI [1])
C0015250 (UMLS CUI [2])
C0023928 (UMLS CUI [3])
C0396580 (UMLS CUI [4])
C0032284 (UMLS CUI [5])
C1709603 (UMLS CUI [6])
C1300901 (UMLS CUI [7,1])
C1522718 (UMLS CUI [7,2])
Mediastinal lymph node Exploration | Sampling of lymph node | Lymph Node Dissection systematic | Primary malignant neoplasm of right lung Upper | Primary malignant neoplasm of right lung Middle | Primary malignant neoplasm of right lung Lower | Primary malignant neoplasm of left lung Upper | Primary malignant neoplasm of left lung Lower
Item
3. mediastinal lymph node exploration (lymph node sampling or systematic dissection of lymph nodes at stations 2, 4 and 7 in case of upper/middle right-sided lung cancer; 4, 7, 8 and 9 in case of lower right-sided lung cancer; 5, 6 and 7 in case of upper left -sided lung cancer; 7, 8 and 9 in case of lower left-sided lung cancer is recommended)
boolean
C0588055 (UMLS CUI [1,1])
C1280903 (UMLS CUI [1,2])
C0398417 (UMLS CUI [2])
C0242382 (UMLS CUI [3,1])
C0220922 (UMLS CUI [3,2])
C3862551 (UMLS CUI [4,1])
C1282910 (UMLS CUI [4,2])
C3862551 (UMLS CUI [5,1])
C0444598 (UMLS CUI [5,2])
C3862551 (UMLS CUI [6,1])
C0441994 (UMLS CUI [6,2])
C3862552 (UMLS CUI [7,1])
C1282910 (UMLS CUI [7,2])
C3862552 (UMLS CUI [8,1])
C0441994 (UMLS CUI [8,2])
TNM clinical staging | Mediastinal lymph node Involvement | Operative Surgical Procedures | Preoperative Chemotherapy Absent | Status pre- Preoperative Chemotherapy
Item
4. pathologically or cytologically documented n2 mediastinal nodal involvement, at the time of surgery if no preoperative chemotherapy or before preoperative chemotherapy, according to the criteria of the joint ajcc and uicc classification, clinical n2 patients without cytological or histological documentation of mediastinal node involvement before preoperative chemotherapy can be included in the study if and only if, they have histologically confirmed n2 disease at the time of surgery
boolean
C3258246 (UMLS CUI [1])
C0588055 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3])
C2347669 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0332152 (UMLS CUI [5,1])
C2347669 (UMLS CUI [5,2])
Prior Chemotherapy | Adjuvant Chemotherapy Preoperative | Adjuvant Chemotherapy Postoperative
Item
5. prior chemotherapy is allowed (pre-operative or post-operative adjuvant chemotherapy, or both)
boolean
C1514457 (UMLS CUI [1])
C0085533 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3,1])
C0032790 (UMLS CUI [3,2])
Age
Item
6. patient aged ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
7. good performance status (who ≤ 2)
boolean
C1298650 (UMLS CUI [1])
Fit Therapeutic radiology procedure Curative
Item
8. fit enough to receive curative radiotherapy
boolean
C0424576 (UMLS CUI [1,1])
C1522449 (UMLS CUI [1,2])
C1276305 (UMLS CUI [1,3])
Pulmonary function | FEV1 Postoperative
Item
9. adequate pulmonary function with post-operative fev1 after surgery > 1 l or over 35% theoretical value
boolean
C0231921 (UMLS CUI [1])
C0849974 (UMLS CUI [2,1])
C0032790 (UMLS CUI [2,2])
Informed Consent
Item
10. signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis | Exception Nodule Ipsilateral Lung lobe Different | Status post Pneumonectomy | Status post Bilobectomy of lung
Item
1. documented metastases, (except for ipsilateral nodule(s) in a different lobe after pneumonectomy or bi-lobectomy)
boolean
C0027627 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0028259 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
C0225752 (UMLS CUI [2,4])
C1705242 (UMLS CUI [2,5])
C0231290 (UMLS CUI [3,1])
C0032284 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0396580 (UMLS CUI [4,2])
Pleural effusion disorder Major | Pericardial effusion Major
Item
2. major pleural or pericardial effusion
boolean
C0032227 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0031039 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Malignant neoplasm of lung Contralateral Synchronous
Item
3. synchronous contra-lateral lung cancer
boolean
C0242379 (UMLS CUI [1,1])
C0441988 (UMLS CUI [1,2])
C0439580 (UMLS CUI [1,3])
Disease Progression During Postoperative chemotherapy
Item
4. clinical progression during post-operative chemotherapy
boolean
C0242656 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1273551 (UMLS CUI [1,3])
Radiotherapy to thorax
Item
5. previous chest radiotherapy
boolean
C4038705 (UMLS CUI [1])
Chemotherapy During Therapeutic radiology procedure
Item
6. intention of concomitant chemotherapy during radiotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
Weight decreased Preoperative Percentage
Item
7. weight loss in the previous 6 months before surgery ≥ 10 %
boolean
C1262477 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Systemic disease Severe | Systemic disease Uncontrolled
Item
8. evidence of severe or uncontrolled systemic disease as judged by the investigator
boolean
C0442893 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0442893 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Heart Disease Severe | Cardiac Arrhythmia | Congestive heart failure | Infarction | Artificial cardiac pacemaker | Lung diseases
Item
9. recent (< 6 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction, pace-maker) or pulmonary disease
boolean
C0018799 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0021308 (UMLS CUI [4])
C0030163 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
Neoplasms | Exception Non-Small Cell Lung Carcinoma
Item
10. current or past history of neoplasm other than non-small cell lung cancer diagnosed within the last 5 years, except :
boolean
C0027651 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
Basal cell carcinoma
Item
basal cell carcinoma of the skin
boolean
C0007117 (UMLS CUI [1])
Carcinoma in situ of uterine cervix | Inclusion criteria Cancer Other Cured
Item
in situ carcinoma of the cervix a patient diagnosed for another neoplasm 5 years ago or more, treated and considered as cured may be included in the study if all the other criteria are respected.
boolean
C0851140 (UMLS CUI [1])
C1512693 (UMLS CUI [2,1])
C1707251 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Contraceptive methods Inadequate
Item
11. pregnancy or breast feeding or inadequate contraceptive measures during treatment
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Factor Familial Follow-up Inadequate | Social Conditions Follow-up Inadequate | Geographic Factors Follow-up Inadequate | Mental condition Follow-up Inadequate | Factor Familial Control Unsuccessful | Social Conditions Control Unsuccessful | Geographic Factors Control Unsuccessful | Mental condition Control Unsuccessful
Item
12. patients who, for family, social, geographic or psychological reasons, cannot be adequately followed up and/or are incapable of undergoing regular controls
boolean
C1521761 (UMLS CUI [1,1])
C0241888 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0205412 (UMLS CUI [1,4])
C0037403 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0205412 (UMLS CUI [2,3])
C0017444 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0205412 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C3274571 (UMLS CUI [4,2])
C0205412 (UMLS CUI [4,3])
C1521761 (UMLS CUI [5,1])
C0241888 (UMLS CUI [5,2])
C0243148 (UMLS CUI [5,3])
C1272705 (UMLS CUI [5,4])
C0037403 (UMLS CUI [6,1])
C0243148 (UMLS CUI [6,2])
C1272705 (UMLS CUI [6,3])
C0017444 (UMLS CUI [7,1])
C0243148 (UMLS CUI [7,2])
C1272705 (UMLS CUI [7,3])
C3840291 (UMLS CUI [8,1])
C0243148 (UMLS CUI [8,2])
C1272705 (UMLS CUI [8,3])
Patient Deprivation Freedom | Guardianship of Patient
Item
13. patient deprived of freedom or under guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0016694 (UMLS CUI [1,3])
C0680611 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
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