ID

38155

Description

Proton Radiation for Stage II/III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01758445

Lien

https://clinicaltrials.gov/show/NCT01758445

Mots-clés

Versions (1)
  1. 23/09/2019 23/09/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

23 septembre 2019

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01758445

Anglais

Eligibility Breast Cancer NCT01758445

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. must sign study-specific, irb approved informed consent form prior to study entry. note consent by legally authorized representative is not allowed for this trial.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. must be > = 18 years of age.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
Description

Life Expectancy | Age Related | Comorbidity Related | Breast Carcinoma Excluded

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0439849
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0439849
UMLS CUI [4,1]
C0678222
UMLS CUI [4,2]
C0332196
4. must have pathology proven breast cancer. pathology must be invasive ductal or lobular
Description

Breast Carcinoma | Invasive Ductal Breast Carcinoma | Lobular breast cancer Invasive

Type de données

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C1134719
UMLS CUI [3,1]
C3549742
UMLS CUI [3,2]
C0205281
5. must meet stage ii - iii group criteria per ajcc staging manual 7th edition.
Description

TNM Breast tumor staging

Type de données

boolean

Alias
UMLS CUI [1]
C0474926
6. must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. re-excision of surgical margins is permitted.
Description

Operation on breast | Mastectomy | Breast-Conserving Surgery | Segmental Mastectomy | Reexcision Surgical margins allowed

Type de données

boolean

Alias
UMLS CUI [1]
C3714726
UMLS CUI [2]
C0024881
UMLS CUI [3]
C0917927
UMLS CUI [4]
C0024885
UMLS CUI [5,1]
C0184913
UMLS CUI [5,2]
C0229985
UMLS CUI [5,3]
C0683607
7. note: multicentric breast cancer and paget's disease of the nipple are permitted.
Description

Multicentric Breast Carcinoma allowed | Paget Disease allowed

Type de données

boolean

Alias
UMLS CUI [1,1]
C2986664
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C1368019
UMLS CUI [2,2]
C0683607
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. weight over 410 pounds.
Description

Body Weight Pounds Quantity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0439219
UMLS CUI [1,3]
C1265611
2. non-epithelial breast malignancies such as sarcoma or lymphoma.
Description

Malignant neoplasm of breast Not involving Epithelium | Sarcoma of breast | Breast Lymphoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0205429
UMLS CUI [1,3]
C0014609
UMLS CUI [2]
C0349667
UMLS CUI [3]
C1704251
3. surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (if surgical margins are rendered free of disease by re-excision, the patient is eligible).
Description

Surgical margins | Assessment Microscopic Unsuccessful | Positive Surgical Margins | Exception Reexcision Surgical margins | Exception Surgical margins Free of Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0229985
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0205288
UMLS CUI [2,3]
C1272705
UMLS CUI [3]
C1709603
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0184913
UMLS CUI [4,3]
C0229985
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0229985
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0012634
4. breast size exceeding the technical limitation of daily set-up reproducibility. this may be center-specific and will be assessed at the discretion of the treating center.
Description

Problem with female breast size Limitation Technical Problem

Type de données

boolean

Alias
UMLS CUI [1,1]
C0850669
UMLS CUI [1,2]
C0449295
UMLS CUI [1,3]
C1710348
5. women with post-surgical temporary breast expanders will require individual assessment. depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
Description

Breast tissue expander Postoperative Temporary | Requirement Individual needs assessment

Type de données

boolean

Alias
UMLS CUI [1,1]
C0588162
UMLS CUI [1,2]
C0032790
UMLS CUI [1,3]
C0205374
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0679839
6. prior history of breast cancer.
Description

Breast Carcinoma Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
7. prior radiation to the breast or thorax.
Description

Irradiation of breast Previous | Radiotherapy to thorax Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C2148528
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C4038705
UMLS CUI [2,2]
C0205156
8. collagen vascular disease, specifically dermatomyositis with a cpk level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
Description

Collagen-vascular disease | Dermatomyositis | Elevated creatine kinase | Exanthema | Lupus Erythematosus, Systemic | Scleroderma

Type de données

boolean

Alias
UMLS CUI [1]
C0262428
UMLS CUI [2]
C0011633
UMLS CUI [3]
C0151576
UMLS CUI [4]
C0015230
UMLS CUI [5]
C0024141
UMLS CUI [6]
C0011644
9. pregnancy or lactation at the time of proposed study entry. women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (note: women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration).
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Exception Hormonal contraception | Childbearing Potential Serum pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0221829
UMLS CUI [6]
C0087145
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C2985296
UMLS CUI [8,1]
C3831118
UMLS CUI [8,2]
C0430061
10. psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Description

Mental disorders Protocol Compliance Excluded | Addictive Behavior Protocol Compliance Excluded | Condition Protocol Compliance Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0525058
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0085281
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0525058
UMLS CUI [3,3]
C0332196
11. prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.
Description

Cancer Other | Exception Disease Free Duration | Exception Low Risk Recurrence | Exception Carcinoma in situ of uterine cervix Treated | Exception Colon Carcinoma In situ Treated | Exception Malignant melanoma in situ Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3538919
UMLS CUI [3,3]
C0034897
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0699790
UMLS CUI [5,3]
C0444498
UMLS CUI [5,4]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0854696
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0007117
UMLS CUI [7,3]
C1522326
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0553723
UMLS CUI [8,3]
C1522326
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Similar models

Eligibility Breast Cancer NCT01758445

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. must sign study-specific, irb approved informed consent form prior to study entry. note consent by legally authorized representative is not allowed for this trial.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. must be > = 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy | Age Related | Comorbidity Related | Breast Carcinoma Excluded
Item
3. must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
boolean
C0023671 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
Breast Carcinoma | Invasive Ductal Breast Carcinoma | Lobular breast cancer Invasive
Item
4. must have pathology proven breast cancer. pathology must be invasive ductal or lobular
boolean
C0678222 (UMLS CUI [1])
C1134719 (UMLS CUI [2])
C3549742 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
TNM Breast tumor staging
Item
5. must meet stage ii - iii group criteria per ajcc staging manual 7th edition.
boolean
C0474926 (UMLS CUI [1])
Operation on breast | Mastectomy | Breast-Conserving Surgery | Segmental Mastectomy | Reexcision Surgical margins allowed
Item
6. must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. re-excision of surgical margins is permitted.
boolean
C3714726 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
C0917927 (UMLS CUI [3])
C0024885 (UMLS CUI [4])
C0184913 (UMLS CUI [5,1])
C0229985 (UMLS CUI [5,2])
C0683607 (UMLS CUI [5,3])
Multicentric Breast Carcinoma allowed | Paget Disease allowed
Item
7. note: multicentric breast cancer and paget's disease of the nipple are permitted.
boolean
C2986664 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C1368019 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Body Weight Pounds Quantity
Item
1. weight over 410 pounds.
boolean
C0005910 (UMLS CUI [1,1])
C0439219 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Malignant neoplasm of breast Not involving Epithelium | Sarcoma of breast | Breast Lymphoma
Item
2. non-epithelial breast malignancies such as sarcoma or lymphoma.
boolean
C0006142 (UMLS CUI [1,1])
C0205429 (UMLS CUI [1,2])
C0014609 (UMLS CUI [1,3])
C0349667 (UMLS CUI [2])
C1704251 (UMLS CUI [3])
Surgical margins | Assessment Microscopic Unsuccessful | Positive Surgical Margins | Exception Reexcision Surgical margins | Exception Surgical margins Free of Disease
Item
3. surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (if surgical margins are rendered free of disease by re-excision, the patient is eligible).
boolean
C0229985 (UMLS CUI [1])
C1516048 (UMLS CUI [2,1])
C0205288 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C1709603 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0184913 (UMLS CUI [4,2])
C0229985 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0229985 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0012634 (UMLS CUI [5,4])
Problem with female breast size Limitation Technical Problem
Item
4. breast size exceeding the technical limitation of daily set-up reproducibility. this may be center-specific and will be assessed at the discretion of the treating center.
boolean
C0850669 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
C1710348 (UMLS CUI [1,3])
Breast tissue expander Postoperative Temporary | Requirement Individual needs assessment
Item
5. women with post-surgical temporary breast expanders will require individual assessment. depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
boolean
C0588162 (UMLS CUI [1,1])
C0032790 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0679839 (UMLS CUI [2,2])
Breast Carcinoma Previous
Item
6. prior history of breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Irradiation of breast Previous | Radiotherapy to thorax Previous
Item
7. prior radiation to the breast or thorax.
boolean
C2148528 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C4038705 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Collagen-vascular disease | Dermatomyositis | Elevated creatine kinase | Exanthema | Lupus Erythematosus, Systemic | Scleroderma
Item
8. collagen vascular disease, specifically dermatomyositis with a cpk level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
boolean
C0262428 (UMLS CUI [1])
C0011633 (UMLS CUI [2])
C0151576 (UMLS CUI [3])
C0015230 (UMLS CUI [4])
C0024141 (UMLS CUI [5])
C0011644 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Intrauterine Devices | Female Condoms | Vaginal Spermicides | Exception Hormonal contraception | Childbearing Potential Serum pregnancy test negative
Item
9. pregnancy or lactation at the time of proposed study entry. women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (note: women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0021900 (UMLS CUI [4])
C0221829 (UMLS CUI [5])
C0087145 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C2985296 (UMLS CUI [7,2])
C3831118 (UMLS CUI [8,1])
C0430061 (UMLS CUI [8,2])
Mental disorders Protocol Compliance Excluded | Addictive Behavior Protocol Compliance Excluded | Condition Protocol Compliance Excluded
Item
10. psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
boolean
C0004936 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0085281 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0525058 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Cancer Other | Exception Disease Free Duration | Exception Low Risk Recurrence | Exception Carcinoma in situ of uterine cervix Treated | Exception Colon Carcinoma In situ Treated | Exception Malignant melanoma in situ Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
11. prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3538919 (UMLS CUI [3,2])
C0034897 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699790 (UMLS CUI [5,2])
C0444498 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0854696 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0007117 (UMLS CUI [7,2])
C1522326 (UMLS CUI [7,3])
C1705847 (UMLS CUI [8,1])
C0553723 (UMLS CUI [8,2])
C1522326 (UMLS CUI [8,3])
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