ID

13097

Description

Radiotherapy Versus Radiotherapy Plus Chemotherapy in Early Stage Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00115700

Link

https://clinicaltrials.gov/show/NCT00115700

Keywords

Versions (1)
  1. 1/15/16 1/15/16 -
Uploaded on

January 15, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Follicular Lymphoma NCT00115700

English

Eligibility Follicular Lymphoma NCT00115700

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients (≥ 18 years old) with histologically documented "follicular lymphoma, grade 1", grade 2", or "follicular lymphoma, grade 3a" diagnosed following an excisional, incisional or generous core biopsy. (i.e. an fna alone is insufficient.)
Description

age, follicular lymphoma grade, biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0024301
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0919553
disease limited to stages i and ii after adequate staging
Description

disease stage

Data type

boolean

Alias
UMLS CUI [1]
C0699749
anticipated life expectancy > 5 years
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
given written informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
been assessed by a radiation oncologist and a medical oncologist/ haematologist
Description

assessment

Data type

boolean

Alias
UMLS CUI [1]
C1516048
wcc > 3.0 x 10^9/l, platelet count > 100 x 10^9/l, serum creatinine < 0.15 mmol/l
Description

wbc, platelet count, creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0032181
ability to commence radiotherapy within 6 weeks of randomisation
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1321605
women using effective contraception, are not pregnant and agree not to become pregnant during participating in the trial and during the 12 months thereafter. men agree not to father a child during participation in the trial and during the 12 months thereafter.
Description

contraception, pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0032961
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
received previous systemic cytotoxic chemotherapy.
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
received previous radiotherapy, (except superficial radiation therapy for non-melanoma skin cancers).
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
received previous immunotherapy.
Description

immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0021083
a medical contraindication to radiotherapy, chemotherapy, or rituximab.
Description

contraindication

Data type

boolean

Alias
UMLS CUI [1]
C1301624
any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years.
Description

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
such extensive involvement of the thorax that treatment with radiation therapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed.
Description

thoracic involvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0817096
UMLS CUI [1,2]
C0449290
suspected or confirmed pregnancy. must not be lactating.
Description

pregnancy, lactation

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients who have known human immuno-deficiency virus (hiv) infection or active hepatitis b (hbv).
Description

hiv, hbv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
treatment within a clinical study within 30 days prior to study entry.
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Follicular Lymphoma NCT00115700

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age, follicular lymphoma grade, biopsy
Item
adult patients (≥ 18 years old) with histologically documented "follicular lymphoma, grade 1", grade 2", or "follicular lymphoma, grade 3a" diagnosed following an excisional, incisional or generous core biopsy. (i.e. an fna alone is insufficient.)
boolean
C0001779 (UMLS CUI [1])
C0024301 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0919553 (UMLS CUI [2,3])
disease stage
Item
disease limited to stages i and ii after adequate staging
boolean
C0699749 (UMLS CUI [1])
life expectancy
Item
anticipated life expectancy > 5 years
boolean
C0023671 (UMLS CUI [1])
informed consent
Item
given written informed consent
boolean
C0021430 (UMLS CUI [1])
assessment
Item
been assessed by a radiation oncologist and a medical oncologist/ haematologist
boolean
C1516048 (UMLS CUI [1])
wbc, platelet count, creatinine
Item
wcc > 3.0 x 10^9/l, platelet count > 100 x 10^9/l, serum creatinine < 0.15 mmol/l
boolean
C0023508 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
radiotherapy
Item
ability to commence radiotherapy within 6 weeks of randomisation
boolean
C1522449 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
contraception, pregnancy
Item
women using effective contraception, are not pregnant and agree not to become pregnant during participating in the trial and during the 12 months thereafter. men agree not to father a child during participation in the trial and during the 12 months thereafter.
boolean
C0700589 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
chemotherapy
Item
received previous systemic cytotoxic chemotherapy.
boolean
C0392920 (UMLS CUI [1])
radiotherapy
Item
received previous radiotherapy, (except superficial radiation therapy for non-melanoma skin cancers).
boolean
C1522449 (UMLS CUI [1])
immunotherapy
Item
received previous immunotherapy.
boolean
C0021083 (UMLS CUI [1])
contraindication
Item
a medical contraindication to radiotherapy, chemotherapy, or rituximab.
boolean
C1301624 (UMLS CUI [1])
malignancy
Item
any previous or concurrent malignancy other than curatively treated non-melanoma skin cancer, level 1 malignant melanoma, or in situ cervical cancer, unless disease and treatment-free for 5 years.
boolean
C0006826 (UMLS CUI [1])
thoracic involvement
Item
such extensive involvement of the thorax that treatment with radiation therapy alone would be hazardous because of excessive lung irradiation, even if a shrinking field technique were employed.
boolean
C0817096 (UMLS CUI [1,1])
C0449290 (UMLS CUI [1,2])
pregnancy, lactation
Item
suspected or confirmed pregnancy. must not be lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
hiv, hbv
Item
patients who have known human immuno-deficiency virus (hiv) infection or active hepatitis b (hbv).
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
study subject participation status
Item
treatment within a clinical study within 30 days prior to study entry.
boolean
C2348568 (UMLS CUI [1])
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