ID

42934

Description

Study Comparing Two Treatments in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT01528163

Link

https://clinicaltrials.gov/show/NCT01528163

Keywords

Versions (2)
  1. 1/3/16 1/3/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma of the Head and Neck NCT01528163

English

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT01528163

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation.
Description

head and neck squamous cell carcinoma Recurrent; Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C2945760
UMLS CUI [2]
C0027627
2. at least one measurable lesion by mri or ct-scan according to recist 1.1.
Description

lesion measurable

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1513040
3. progressive disease within 1 year after first line platinum-based chemotherapy given either as a part of the multimodal curative treatment or in the palliative setting.
Description

progressive disease; chemotherapy platinum-based

Data type

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C3665472
UMLS CUI [2,2]
C1514162
4. ecog performance status 0 -2, in stable medical condition
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
5. patients must have an expected survival of at least 3 months
Description

expected survival

Data type

boolean

Alias
UMLS CUI [1]
C0023671
6. paraffin-embedded tumor tissue available for immunohistochemistry but not mandatory
Description

tumor tissue paraffin-embedded; immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0085185
UMLS CUI [2]
C0021044
7. patients must be over 18 years old and must be able to give written informed consent.
Description

age; informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
8. women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment).
Description

negative pregnancy test; Fertility Female

Data type

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2,1]
C0015895
UMLS CUI [2,2]
C0086287
9. patients must have adequate organ function (hemoglobin ≥ 9 g/100 ml, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3, total bilirubin <1 time the upper limit of normal (uln) for age, serum alanine aminotransferase (alt) < 1.5 1.5 x uln for age, aspartate aminotransferase (ast) < 1.5 ´ uln for age , serum creatinine <1.5 x uln for age.
Description

organ function adequate; Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205411
UMLS CUI [2]
C0518015
10. signed informed consent prior to beginning protocol specific procedure.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
11. sexually active patients must use effective contraception during the period of therapy and up to 150 days after the last treatment dose. acceptable contraception includes, but is not limited to: oral hormone therapy, partner vasectomy, or double barrier contraception (which is defined as a male condom plus spermicide in combination with either a female condom, or diaphragm, or cervical cap or intrauterine device)
Description

Contraceptive methods; vasectomy

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C0042387
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. non-squamous head and neck cancer
Description

head and neck cancer

Data type

boolean

Alias
UMLS CUI [1]
C0278996
2. nasopharynx cancer
Description

nasopharynx cancer

Data type

boolean

Alias
UMLS CUI [1]
C0238301
3. more than two lines of chemotherapy for palliative treatment
Description

chemotherapy palliative treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0920416
4. surgery or investigational drugs or chemotherapy within 4 weeks before study inclusion. curative radiation therapy (60-70 gy) within 8 weeks. for palliative radiation therapy (i.e 8 gy on a painful lesion) no delay is needed.
Description

chemotherapy; surgery

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0543467
5. previous treatment with cabazitaxel
Description

cabazitaxel

Data type

boolean

Alias
UMLS CUI [1]
C2830183
6. significant active cardiac disease including: uncontrolled high blood pressure according to the ctcae 4 grading, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias
Description

cardiac disease; Blood Pressure; congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0005823
UMLS CUI [3]
C0018802
7. other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
8. previous malignancy from which the patient has been disease-free for < 5years, as other than scchn.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
9. previous treatments with taxanes and/or anti-egfr therapy are not an exclusion criteria.
Description

taxanes

Data type

boolean

Alias
UMLS CUI [1]
C3541958
10. active grade > 2 peripheral neuropathy
Description

grade; peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0441800
UMLS CUI [2]
C0031117
11. active grade > 2 stomatitis
Description

grade; stomatitis

Data type

boolean

Alias
UMLS CUI [1]
C0441800
UMLS CUI [2]
C0038362
12. known brain or leptomeningeal involvement
Description

Site of involvement leptomeningeal Brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0449683
UMLS CUI [1,2]
C0521401
UMLS CUI [1,3]
C0006104
13. history of severe hypersensitivity reaction (> grade 3) to polysorbate 80 containing drugs
Description

hypersensitivity polysorbate 80

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0032601
14. concurrent or planned treatment with strong inhibitors of cytochrome p450 3a/5. a one-week washout period is necessary for patients who are already on these treatments.
Description

treatment concurrent

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205420
15. organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
Description

organic brain syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0029221
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Similar models

Eligibility Squamous Cell Carcinoma of the Head and Neck NCT01528163

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
head and neck squamous cell carcinoma Recurrent; Neoplasm Metastasis
Item
1. recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation.
boolean
C1168401 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
lesion measurable
Item
2. at least one measurable lesion by mri or ct-scan according to recist 1.1.
boolean
C0221198 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
progressive disease; chemotherapy platinum-based
Item
3. progressive disease within 1 year after first line platinum-based chemotherapy given either as a part of the multimodal curative treatment or in the palliative setting.
boolean
C1335499 (UMLS CUI [1])
C3665472 (UMLS CUI [2,1])
C1514162 (UMLS CUI [2,2])
ecog performance status
Item
4. ecog performance status 0 -2, in stable medical condition
boolean
C1520224 (UMLS CUI [1])
expected survival
Item
5. patients must have an expected survival of at least 3 months
boolean
C0023671 (UMLS CUI [1])
tumor tissue paraffin-embedded; immunohistochemistry
Item
6. paraffin-embedded tumor tissue available for immunohistochemistry but not mandatory
boolean
C0475358 (UMLS CUI [1,1])
C0085185 (UMLS CUI [1,2])
C0021044 (UMLS CUI [2])
age; informed consent
Item
7. patients must be over 18 years old and must be able to give written informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
negative pregnancy test; Fertility Female
Item
8. women of child-bearing age or sexually active female patients with reproductive potential must have a negative pregnancy test (serum or urine within the 7 days prior to enrollment).
boolean
C0427780 (UMLS CUI [1])
C0015895 (UMLS CUI [2,1])
C0086287 (UMLS CUI [2,2])
organ function adequate; Hemoglobin measurement
Item
9. patients must have adequate organ function (hemoglobin ≥ 9 g/100 ml, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3, total bilirubin <1 time the upper limit of normal (uln) for age, serum alanine aminotransferase (alt) < 1.5 1.5 x uln for age, aspartate aminotransferase (ast) < 1.5 ´ uln for age , serum creatinine <1.5 x uln for age.
boolean
C0678852 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
informed consent
Item
10. signed informed consent prior to beginning protocol specific procedure.
boolean
C0021430 (UMLS CUI [1])
Contraceptive methods; vasectomy
Item
11. sexually active patients must use effective contraception during the period of therapy and up to 150 days after the last treatment dose. acceptable contraception includes, but is not limited to: oral hormone therapy, partner vasectomy, or double barrier contraception (which is defined as a male condom plus spermicide in combination with either a female condom, or diaphragm, or cervical cap or intrauterine device)
boolean
C0700589 (UMLS CUI [1])
C0042387 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
head and neck cancer
Item
1. non-squamous head and neck cancer
boolean
C0278996 (UMLS CUI [1])
nasopharynx cancer
Item
2. nasopharynx cancer
boolean
C0238301 (UMLS CUI [1])
chemotherapy palliative treatment
Item
3. more than two lines of chemotherapy for palliative treatment
boolean
C0392920 (UMLS CUI [1,1])
C0920416 (UMLS CUI [1,2])
chemotherapy; surgery
Item
4. surgery or investigational drugs or chemotherapy within 4 weeks before study inclusion. curative radiation therapy (60-70 gy) within 8 weeks. for palliative radiation therapy (i.e 8 gy on a painful lesion) no delay is needed.
boolean
C0392920 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
cabazitaxel
Item
5. previous treatment with cabazitaxel
boolean
C2830183 (UMLS CUI [1])
cardiac disease; Blood Pressure; congestive heart failure
Item
6. significant active cardiac disease including: uncontrolled high blood pressure according to the ctcae 4 grading, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias
boolean
C0018799 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
comorbidity
Item
7. other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
boolean
C0009488 (UMLS CUI [1])
Malignant Neoplasms
Item
8. previous malignancy from which the patient has been disease-free for < 5years, as other than scchn.
boolean
C0006826 (UMLS CUI [1])
taxanes
Item
9. previous treatments with taxanes and/or anti-egfr therapy are not an exclusion criteria.
boolean
C3541958 (UMLS CUI [1])
grade; peripheral neuropathy
Item
10. active grade > 2 peripheral neuropathy
boolean
C0441800 (UMLS CUI [1])
C0031117 (UMLS CUI [2])
grade; stomatitis
Item
11. active grade > 2 stomatitis
boolean
C0441800 (UMLS CUI [1])
C0038362 (UMLS CUI [2])
Site of involvement leptomeningeal Brain
Item
12. known brain or leptomeningeal involvement
boolean
C0449683 (UMLS CUI [1,1])
C0521401 (UMLS CUI [1,2])
C0006104 (UMLS CUI [1,3])
hypersensitivity polysorbate 80
Item
13. history of severe hypersensitivity reaction (> grade 3) to polysorbate 80 containing drugs
boolean
C0020517 (UMLS CUI [1,1])
C0032601 (UMLS CUI [1,2])
treatment concurrent
Item
14. concurrent or planned treatment with strong inhibitors of cytochrome p450 3a/5. a one-week washout period is necessary for patients who are already on these treatments.
boolean
C0087111 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
organic brain syndrome
Item
15. organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
boolean
C0029221 (UMLS CUI [1])
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