ID

31143

Beschreibung

Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00840749

Link

https://clinicaltrials.gov/show/NCT00840749

Stichworte

Versionen (2)
  1. 23.07.18 23.07.18 -
  2. 23.07.18 23.07.18 -
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See clinicaltrials.gov

Hochgeladen am

23. Juli 2018

DOI

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Creative Commons BY-NC 3.0
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Eligibility Non-small Cell Lung Cancer NCT00840749

Englisch

Eligibility Non-small Cell Lung Cancer NCT00840749

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological confirmation of non-small cell cancer will be required by either biopsy or cytology. the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without bac features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.
Beschreibung

Non-small cell carcinoma | Squamous cell carcinoma | Adenocarcinoma | Bronchioalveolar carcinoma Feature | Bronchioalveolar carcinoma Feature Absent | Carcinoma, Large Cell | Feature Neuroendocrine | Feature Neuroendocrine Absent | Carcinoma, Neuroendocrine | Bronchioloalveolar carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C1266002
UMLS CUI [2]
C0007137
UMLS CUI [3]
C0001418
UMLS CUI [4,1]
C0007120
UMLS CUI [4,2]
C2348519
UMLS CUI [5,1]
C0007120
UMLS CUI [5,2]
C2348519
UMLS CUI [5,3]
C0332197
UMLS CUI [6]
C0206704
UMLS CUI [7,1]
C2348519
UMLS CUI [7,2]
C0027912
UMLS CUI [8,1]
C2348519
UMLS CUI [8,2]
C0027912
UMLS CUI [8,3]
C0332197
UMLS CUI [9]
C0206695
UMLS CUI [10]
C0007120
2. eligible patients must have appropriate staging studies identifying them as specific subsets of the revised iascl state ia or ib based on only one of the following combinations of tnm staging:
Beschreibung

Stage, non-small cell lung cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0280217
t1, n0, m0 or t2 (<=4 cm), n0, m0
Beschreibung

TNM clinical staging

Datentyp

boolean

Alias
UMLS CUI [1]
C3258246
3. a pet/ct scan is required. patients with hilar or mediastinal lymph nodes with short axis diameter < 1 cm and no abnormal hilar or mediastinal uptake on pet will be considered n0. patients with > 1 cm short axis diameter of hilar or mediastinal lymph nodes on ct or abnormal pet (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. solitary pulmonary lesions <4 mm will not be considered significant.
Beschreibung

Hilar lymph node PET/CT scan | Mediastinal lymph nodes PET/CT scan | Hilar lymph node Short axis Diameter | Mediastinal lymph nodes Short axis Diameter

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1305372
UMLS CUI [1,2]
C1699633
UMLS CUI [2,1]
C0588055
UMLS CUI [2,2]
C1699633
UMLS CUI [3,1]
C1305372
UMLS CUI [3,2]
C0522488
UMLS CUI [3,3]
C1301886
UMLS CUI [4,1]
C0588055
UMLS CUI [4,2]
C0522488
UMLS CUI [4,3]
C1301886
4. the patients must be considered a reasonable candidate for surgical resection of the primary tumor. standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of nsclc may include any of the following: baseline fev1 > 40% predicted, post-operative predicted fev1 > 30% predicted, diffusion capacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption > 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease.
Beschreibung

Patients Appropriate Excision Primary tumor | Pulmonary function Excision Non-Small Cell Lung Carcinoma | FEV1 | FEV1 Postoperative | Diffusion capacity of lung | Hypoxemia Absent | Hypercapnia Absent | Exercise Oxygen consumption measurement | Severe pulmonary hypertension Absent | Cerebral disorder Severe Absent | Heart Diseases Severe Absent | Peripheral Vascular Diseases Severe Absent | Chronic heart disease Severe Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0728940
UMLS CUI [1,4]
C0677930
UMLS CUI [2,1]
C0231921
UMLS CUI [2,2]
C0728940
UMLS CUI [2,3]
C0007131
UMLS CUI [3]
C0849974
UMLS CUI [4,1]
C0849974
UMLS CUI [4,2]
C0032790
UMLS CUI [5]
C0231971
UMLS CUI [6,1]
C0700292
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0020440
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0015259
UMLS CUI [8,2]
C1305742
UMLS CUI [9,1]
C2750273
UMLS CUI [9,2]
C0332197
UMLS CUI [10,1]
C0234387
UMLS CUI [10,2]
C0205082
UMLS CUI [10,3]
C0332197
UMLS CUI [11,1]
C0018799
UMLS CUI [11,2]
C0205082
UMLS CUI [11,3]
C0332197
UMLS CUI [12,1]
C0085096
UMLS CUI [12,2]
C0205082
UMLS CUI [12,3]
C0332197
UMLS CUI [13,1]
C1290386
UMLS CUI [13,2]
C0205082
UMLS CUI [13,3]
C0332197
5. patients must be ≥ 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
6. the patient's zubrod performance status must be zubrod 0-2.
Beschreibung

Zubrod Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C3714786
7. mandatory staging studies: must be done within 8 weeks prior to study entry
Beschreibung

Diagnostic Neoplasm Staging mandatory

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027646
UMLS CUI [1,2]
C1514873
8. patients must sign a study-specific consent form.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
9. patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.
Beschreibung

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with primary tumors > 4 cm;
Beschreibung

Primary tumor Size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0456389
2. patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor)
Beschreibung

Neuroendocrine Carcinoma Well Differentiated | Carcinoid Tumor Well Differentiated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0206695
UMLS CUI [1,2]
C0205615
UMLS CUI [2,1]
C0007095
UMLS CUI [2,2]
C0205615
3. direct evidence of regional or distant metastases after appropriate staging studies, or synchronous primary or prior malignancy in the past 5 years other than nonmelanomatous skin cancer or in situ cancer;
Beschreibung

Neoplasm Metastasis regional | Distant metastasis | Cancer Other | Exception Skin carcinoma | Exception Carcinoma in Situ

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205147
UMLS CUI [2]
C1269798
UMLS CUI [3]
C1707251
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699893
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0007099
4. previous lung or mediastinal radiotherapy;
Beschreibung

Radiotherapy to lung | Radiotherapy to mediastinum

Datentyp

boolean

Alias
UMLS CUI [1]
C0948315
UMLS CUI [2]
C4049191
5. plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression;
Beschreibung

Local Therapy Planned | Radiotherapy fractionation | Operative Surgical Procedures | Exception Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1517925
UMLS CUI [1,2]
C1301732
UMLS CUI [2]
C3161031
UMLS CUI [3]
C0543467
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0242656
6. pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus;
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
7. cannot achieve acceptable srt planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures (see rt techniques).
Beschreibung

Stereotactic Radiotherapy Planning Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1720823
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C1272705
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT00840749

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell carcinoma | Squamous cell carcinoma | Adenocarcinoma | Bronchioalveolar carcinoma Feature | Bronchioalveolar carcinoma Feature Absent | Carcinoma, Large Cell | Feature Neuroendocrine | Feature Neuroendocrine Absent | Carcinoma, Neuroendocrine | Bronchioloalveolar carcinoma
Item
1. histological confirmation of non-small cell cancer will be required by either biopsy or cytology. the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without bac features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.
boolean
C1266002 (UMLS CUI [1])
C0007137 (UMLS CUI [2])
C0001418 (UMLS CUI [3])
C0007120 (UMLS CUI [4,1])
C2348519 (UMLS CUI [4,2])
C0007120 (UMLS CUI [5,1])
C2348519 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C0206704 (UMLS CUI [6])
C2348519 (UMLS CUI [7,1])
C0027912 (UMLS CUI [7,2])
C2348519 (UMLS CUI [8,1])
C0027912 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
C0206695 (UMLS CUI [9])
C0007120 (UMLS CUI [10])
Stage, non-small cell lung cancer
Item
2. eligible patients must have appropriate staging studies identifying them as specific subsets of the revised iascl state ia or ib based on only one of the following combinations of tnm staging:
boolean
C0280217 (UMLS CUI [1])
TNM clinical staging
Item
t1, n0, m0 or t2 (<=4 cm), n0, m0
boolean
C3258246 (UMLS CUI [1])
Hilar lymph node PET/CT scan | Mediastinal lymph nodes PET/CT scan | Hilar lymph node Short axis Diameter | Mediastinal lymph nodes Short axis Diameter
Item
3. a pet/ct scan is required. patients with hilar or mediastinal lymph nodes with short axis diameter < 1 cm and no abnormal hilar or mediastinal uptake on pet will be considered n0. patients with > 1 cm short axis diameter of hilar or mediastinal lymph nodes on ct or abnormal pet (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. solitary pulmonary lesions <4 mm will not be considered significant.
boolean
C1305372 (UMLS CUI [1,1])
C1699633 (UMLS CUI [1,2])
C0588055 (UMLS CUI [2,1])
C1699633 (UMLS CUI [2,2])
C1305372 (UMLS CUI [3,1])
C0522488 (UMLS CUI [3,2])
C1301886 (UMLS CUI [3,3])
C0588055 (UMLS CUI [4,1])
C0522488 (UMLS CUI [4,2])
C1301886 (UMLS CUI [4,3])
Patients Appropriate Excision Primary tumor | Pulmonary function Excision Non-Small Cell Lung Carcinoma | FEV1 | FEV1 Postoperative | Diffusion capacity of lung | Hypoxemia Absent | Hypercapnia Absent | Exercise Oxygen consumption measurement | Severe pulmonary hypertension Absent | Cerebral disorder Severe Absent | Heart Diseases Severe Absent | Peripheral Vascular Diseases Severe Absent | Chronic heart disease Severe Absent
Item
4. the patients must be considered a reasonable candidate for surgical resection of the primary tumor. standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of nsclc may include any of the following: baseline fev1 > 40% predicted, post-operative predicted fev1 > 30% predicted, diffusion capacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption > 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease.
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0728940 (UMLS CUI [1,3])
C0677930 (UMLS CUI [1,4])
C0231921 (UMLS CUI [2,1])
C0728940 (UMLS CUI [2,2])
C0007131 (UMLS CUI [2,3])
C0849974 (UMLS CUI [3])
C0849974 (UMLS CUI [4,1])
C0032790 (UMLS CUI [4,2])
C0231971 (UMLS CUI [5])
C0700292 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0020440 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0015259 (UMLS CUI [8,1])
C1305742 (UMLS CUI [8,2])
C2750273 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C0234387 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C0332197 (UMLS CUI [10,3])
C0018799 (UMLS CUI [11,1])
C0205082 (UMLS CUI [11,2])
C0332197 (UMLS CUI [11,3])
C0085096 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
C0332197 (UMLS CUI [12,3])
C1290386 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0332197 (UMLS CUI [13,3])
Age
Item
5. patients must be ≥ 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Zubrod Performance Status
Item
6. the patient's zubrod performance status must be zubrod 0-2.
boolean
C3714786 (UMLS CUI [1])
Diagnostic Neoplasm Staging mandatory
Item
7. mandatory staging studies: must be done within 8 weeks prior to study entry
boolean
C0027646 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Informed Consent
Item
8. patients must sign a study-specific consent form.
boolean
C0021430 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
9. patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Primary tumor Size
Item
1. patients with primary tumors > 4 cm;
boolean
C0677930 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Neuroendocrine Carcinoma Well Differentiated | Carcinoid Tumor Well Differentiated
Item
2. patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor)
boolean
C0206695 (UMLS CUI [1,1])
C0205615 (UMLS CUI [1,2])
C0007095 (UMLS CUI [2,1])
C0205615 (UMLS CUI [2,2])
Neoplasm Metastasis regional | Distant metastasis | Cancer Other | Exception Skin carcinoma | Exception Carcinoma in Situ
Item
3. direct evidence of regional or distant metastases after appropriate staging studies, or synchronous primary or prior malignancy in the past 5 years other than nonmelanomatous skin cancer or in situ cancer;
boolean
C0027627 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2])
C1707251 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0699893 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0007099 (UMLS CUI [5,2])
Radiotherapy to lung | Radiotherapy to mediastinum
Item
4. previous lung or mediastinal radiotherapy;
boolean
C0948315 (UMLS CUI [1])
C4049191 (UMLS CUI [2])
Local Therapy Planned | Radiotherapy fractionation | Operative Surgical Procedures | Exception Disease Progression
Item
5. plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression;
boolean
C1517925 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C3161031 (UMLS CUI [2])
C0543467 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
6. pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Stereotactic Radiotherapy Planning Unsuccessful
Item
7. cannot achieve acceptable srt planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures (see rt techniques).
boolean
C1720823 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
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