ID

37930

Description

Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma in Situ and Early Invasive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01266642

Link

https://clinicaltrials.gov/show/NCT01266642

Keywords

Versions (1)
  1. 8/31/19 8/31/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 31, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01266642

English

Eligibility Breast Cancer NCT01266642

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage tis, t1, or t2, n0, n1mic, or n1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with dcis only). (upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy. for such patients, the criteria for pathologic stage shall be applied to the initial clinical stage)
Description

DCIS Pathologic TNM stage | Invasive carcinoma of breast Early Pathologic TNM stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0007124
UMLS CUI [1,2]
C1319019
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C2363430
UMLS CUI [2,3]
C1319019
2. treatment with breast conserving surgery.
Description

Breast-Conserving Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0917927
3. final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin. if the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a reexcision is strongly encouraged. lobular carcinoma in situ at the final surgical margin will be disregarded.
Description

Negative Surgical Margin | DCIS Absent | Invasive carcinoma of breast Absent

Data type

boolean

Alias
UMLS CUI [1]
C1709157
UMLS CUI [2,1]
C0007124
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0332197
4. age 40 years or older. this age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of ibtr presumably due to underlying biologic differences.
Description

Age | Risk Breast cancer recurrent Ipsilateral | Age Related

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0278493
UMLS CUI [2,3]
C0441989
UMLS CUI [3,1]
C0001779
UMLS CUI [3,2]
C0439849
5. female sex.
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
6. attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level i/ii axilla with high tangents is allowed).
Description

Intention Treatment Whole breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0162425
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0457102
7. if the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.
Description

Cancer Other | Exception Breast Carcinoma | Treatment completed Cancer Other | Cancer Other Disease Free

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0580352
UMLS CUI [3,2]
C1707251
UMLS CUI [4,1]
C1707251
UMLS CUI [4,2]
C0012634
UMLS CUI [4,3]
C0332296
8. patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy.
Description

Patients Enrollment Timespan | Breast-Conserving Surgery | Cytotoxic Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C0872291
UMLS CUI [2]
C0917927
UMLS CUI [3]
C0677881
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pathologic or clinical evidence for a stage t3 or t4 breast cancer.
Description

Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
2. pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes.
Description

Involvement with Axillary lymph nodes Quantity | Involvement with Infraclavicular lymph nodes Imaging | Involvement with Supraclavicular lymph node Imaging | Involvement with Internal Mammary Lymph Node Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0729594
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1314939
UMLS CUI [2,2]
C0229743
UMLS CUI [2,3]
C0011923
UMLS CUI [3,1]
C1314939
UMLS CUI [3,2]
C0229730
UMLS CUI [3,3]
C0011923
UMLS CUI [4,1]
C1314939
UMLS CUI [4,2]
C0229755
UMLS CUI [4,3]
C0011923
3. clinical or pathologic evidence for distant metastases.
Description

Distant metastasis

Data type

boolean

Alias
UMLS CUI [1]
C1269798
4. any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast.
Description

Prior diagnosis Invasive carcinoma of breast | Prior diagnosis DCIS

Data type

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0853879
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C0007124
5. current diagnosis of bilateral breast cancer.
Description

Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
6. history of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast.
Description

Radiotherapy to breast | Radiotherapy to neck Lower | Radiotherapy to mediastinum

Data type

boolean

Alias
UMLS CUI [1]
C0948310
UMLS CUI [2,1]
C1997944
UMLS CUI [2,2]
C0441994
UMLS CUI [3]
C4049191
7. patients not fluent in english or spanish. (the informed consent will be available in these two languages)
Description

Lacking Able to speak fluently English Language | Lacking Able to speak fluently Spanish Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564241
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0332268
UMLS CUI [2,2]
C0564241
UMLS CUI [2,3]
C0037750
8. patient is pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Breast Cancer NCT01266642

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
DCIS Pathologic TNM stage | Invasive carcinoma of breast Early Pathologic TNM stage
Item
1. pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage tis, t1, or t2, n0, n1mic, or n1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with dcis only). (upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy. for such patients, the criteria for pathologic stage shall be applied to the initial clinical stage)
boolean
C0007124 (UMLS CUI [1,1])
C1319019 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C2363430 (UMLS CUI [2,2])
C1319019 (UMLS CUI [2,3])
Breast-Conserving Surgery
Item
2. treatment with breast conserving surgery.
boolean
C0917927 (UMLS CUI [1])
Negative Surgical Margin | DCIS Absent | Invasive carcinoma of breast Absent
Item
3. final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin. if the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a reexcision is strongly encouraged. lobular carcinoma in situ at the final surgical margin will be disregarded.
boolean
C1709157 (UMLS CUI [1])
C0007124 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0853879 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Age | Risk Breast cancer recurrent Ipsilateral | Age Related
Item
4. age 40 years or older. this age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of ibtr presumably due to underlying biologic differences.
boolean
C0001779 (UMLS CUI [1])
C0035647 (UMLS CUI [2,1])
C0278493 (UMLS CUI [2,2])
C0441989 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
Gender
Item
5. female sex.
boolean
C0079399 (UMLS CUI [1])
Intention Treatment Whole breast
Item
6. attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level i/ii axilla with high tangents is allowed).
boolean
C0162425 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0457102 (UMLS CUI [1,3])
Cancer Other | Exception Breast Carcinoma | Treatment completed Cancer Other | Cancer Other Disease Free
Item
7. if the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0580352 (UMLS CUI [3,1])
C1707251 (UMLS CUI [3,2])
C1707251 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Patients Enrollment Timespan | Breast-Conserving Surgery | Cytotoxic Chemotherapy
Item
8. patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy.
boolean
C0030705 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C0917927 (UMLS CUI [2])
C0677881 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging
Item
1. pathologic or clinical evidence for a stage t3 or t4 breast cancer.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
Involvement with Axillary lymph nodes Quantity | Involvement with Infraclavicular lymph nodes Imaging | Involvement with Supraclavicular lymph node Imaging | Involvement with Internal Mammary Lymph Node Imaging
Item
2. pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes.
boolean
C1314939 (UMLS CUI [1,1])
C0729594 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1314939 (UMLS CUI [2,1])
C0229743 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
C1314939 (UMLS CUI [3,1])
C0229730 (UMLS CUI [3,2])
C0011923 (UMLS CUI [3,3])
C1314939 (UMLS CUI [4,1])
C0229755 (UMLS CUI [4,2])
C0011923 (UMLS CUI [4,3])
Distant metastasis
Item
3. clinical or pathologic evidence for distant metastases.
boolean
C1269798 (UMLS CUI [1])
Prior diagnosis Invasive carcinoma of breast | Prior diagnosis DCIS
Item
4. any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast.
boolean
C0332132 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
C0332132 (UMLS CUI [2,1])
C0007124 (UMLS CUI [2,2])
Bilateral breast cancer
Item
5. current diagnosis of bilateral breast cancer.
boolean
C0281267 (UMLS CUI [1])
Radiotherapy to breast | Radiotherapy to neck Lower | Radiotherapy to mediastinum
Item
6. history of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast.
boolean
C0948310 (UMLS CUI [1])
C1997944 (UMLS CUI [2,1])
C0441994 (UMLS CUI [2,2])
C4049191 (UMLS CUI [3])
Lacking Able to speak fluently English Language | Lacking Able to speak fluently Spanish Language
Item
7. patients not fluent in english or spanish. (the informed consent will be available in these two languages)
boolean
C0332268 (UMLS CUI [1,1])
C0564241 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0564241 (UMLS CUI [2,2])
C0037750 (UMLS CUI [2,3])
Pregnancy
Item
8. patient is pregnant.
boolean
C0032961 (UMLS CUI [1])
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