ID

14608

Description

Phase I and II Study Of Stereotactic Body Radiotherapy in Medically Unresectable Patients With Stage 1 NSCLC; ODM derived from: https://clinicaltrials.gov/show/NCT00246181

Link

https://clinicaltrials.gov/show/NCT00246181

Keywords

Versions (1)
  1. 4/24/16 4/24/16 -
Uploaded on

April 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Non-small Cell Lung Cancer NCT00246181

English

Eligibility Non-small Cell Lung Cancer NCT00246181

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
consistent with most therapeutic oncology trials, patients are not actively "recruited," but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit.
Description

Therapeutic oncology trials and routine visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0278627
UMLS CUI [2]
C0545090
all patients must be willing and capable to provide informed consent to participate in the protocol.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
eligible patients must have appropriate staging studies identifying them as ajcc stage i (t1 or t2, n0, m0) primary lung carcinoma. the patient should not have direct evidence of regional or distant metastases after appropriate staging studies. histologic confirmation will be required by either biopsy or cytology. the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell carcinoma or non-small cell; not otherwise specified.
Description

Lung cancer specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0242379
UMLS CUI [1,2]
C0178759
UMLS CUI [2]
C0005558
UMLS CUI [3]
C0010819
UMLS CUI [4]
C0007137
UMLS CUI [5]
C0001418
UMLS CUI [6]
C0206704
UMLS CUI [7]
C0007120
UMLS CUI [8]
C0007131
the primary tumor must be deemed technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection, pcr); however, the patient should have underlying physiological medical problems that would prohibit a pcr due to a low probability of tolerating general anesthesia, the operation, the post-operative recovery period, or the removal of adjacent functioning lung. standard "cut-off " guidelines regarding surgical resection of nsclc include the following: baseline fev1 <40%, post-operative predicted fev1 <30%, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia and exercise oxygen consumption <50% predicted.
Description

Resection technique and pulmonary function

Data type

boolean

Alias
UMLS CUI [1]
C0015252
UMLS CUI [2]
C0748133
UMLS CUI [3]
C0231971
UMLS CUI [4]
C0202155
UMLS CUI [5]
C0020440
patients who refuse a pcr due to preference, ideology, emotional or psychological issues, mental illness, or inability to give consent for the pcr and who have no specific accepted medical contraindications for the pcr are not eligible.
Description

Refuse of resection technique

Data type

boolean

Alias
UMLS CUI [1,1]
C1705116
UMLS CUI [1,2]
C0015252
eligible patients should not have had previous lung or mediastinal radiotherapy.
Description

Lung or mediastinal radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0948315
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0025066
there must be no plans for the patient to receive other concomitant antineoplastic therapy while on this protocol. patients who have received chemotherapy within 8 weeks of the start date of study are ineligible.
Description

Treatment specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0521115
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C2584899
patients must be able to fit inside the stereotactic body frame and able to undergo a ct or mri scan in the frame.
Description

Stereotactic body frame and mri scan

Data type

boolean

Alias
UMLS CUI [1]
C0038270
UMLS CUI [2]
C0024485
the patient's primary tumor must not be larger than 7.0 cm in greatest dimension.
Description

Tumor dimension

Data type

boolean

Alias
UMLS CUI [1]
C1272779
patients with active systemic, pulmonary, or pericardial infection are ineligible.
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
pregnant or lactating women are ineligible. women/men of reproductive potential may not participate unless they agreed to use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (iud), or prescription birth control pills.
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0700589
patients must be past their 18th birthday at time of registration. karnofsky performance status > 60.
Description

Age and karnofsky performance status

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0206065
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
see inclusion criteria.
Description

Exclusion criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
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Similar models

Eligibility Non-small Cell Lung Cancer NCT00246181

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Therapeutic oncology trials and routine visits
Item
consistent with most therapeutic oncology trials, patients are not actively "recruited," but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit.
boolean
C0087111 (UMLS CUI [1,1])
C0278627 (UMLS CUI [1,2])
C0545090 (UMLS CUI [2])
Informed consent
Item
all patients must be willing and capable to provide informed consent to participate in the protocol.
boolean
C0021430 (UMLS CUI [1])
Lung cancer specification
Item
eligible patients must have appropriate staging studies identifying them as ajcc stage i (t1 or t2, n0, m0) primary lung carcinoma. the patient should not have direct evidence of regional or distant metastases after appropriate staging studies. histologic confirmation will be required by either biopsy or cytology. the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell carcinoma or non-small cell; not otherwise specified.
boolean
C0242379 (UMLS CUI [1,1])
C0178759 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
C0010819 (UMLS CUI [3])
C0007137 (UMLS CUI [4])
C0001418 (UMLS CUI [5])
C0206704 (UMLS CUI [6])
C0007120 (UMLS CUI [7])
C0007131 (UMLS CUI [8])
Resection technique and pulmonary function
Item
the primary tumor must be deemed technically resectable by an experienced thoracic cancer clinician, with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection, pcr); however, the patient should have underlying physiological medical problems that would prohibit a pcr due to a low probability of tolerating general anesthesia, the operation, the post-operative recovery period, or the removal of adjacent functioning lung. standard "cut-off " guidelines regarding surgical resection of nsclc include the following: baseline fev1 <40%, post-operative predicted fev1 <30%, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia and exercise oxygen consumption <50% predicted.
boolean
C0015252 (UMLS CUI [1])
C0748133 (UMLS CUI [2])
C0231971 (UMLS CUI [3])
C0202155 (UMLS CUI [4])
C0020440 (UMLS CUI [5])
Refuse of resection technique
Item
patients who refuse a pcr due to preference, ideology, emotional or psychological issues, mental illness, or inability to give consent for the pcr and who have no specific accepted medical contraindications for the pcr are not eligible.
boolean
C1705116 (UMLS CUI [1,1])
C0015252 (UMLS CUI [1,2])
Lung or mediastinal radiotherapy
Item
eligible patients should not have had previous lung or mediastinal radiotherapy.
boolean
C0948315 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0025066 (UMLS CUI [2,2])
Treatment specification
Item
there must be no plans for the patient to receive other concomitant antineoplastic therapy while on this protocol. patients who have received chemotherapy within 8 weeks of the start date of study are ineligible.
boolean
C0920425 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C2584899 (UMLS CUI [2,2])
Stereotactic body frame and mri scan
Item
patients must be able to fit inside the stereotactic body frame and able to undergo a ct or mri scan in the frame.
boolean
C0038270 (UMLS CUI [1])
C0024485 (UMLS CUI [2])
Tumor dimension
Item
the patient's primary tumor must not be larger than 7.0 cm in greatest dimension.
boolean
C1272779 (UMLS CUI [1])
Infection
Item
patients with active systemic, pulmonary, or pericardial infection are ineligible.
boolean
C0009450 (UMLS CUI [1])
Gynaecological status
Item
pregnant or lactating women are ineligible. women/men of reproductive potential may not participate unless they agreed to use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (iud), or prescription birth control pills.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Age and karnofsky performance status
Item
patients must be past their 18th birthday at time of registration. karnofsky performance status > 60.
boolean
C0001779 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Exclusion criteria
Item
see inclusion criteria.
boolean
C0680251 (UMLS CUI [1])
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