ID

41010

Description

Preoperative Treatment With Cetuximab and/or IMC-A12; ODM derived from: https://clinicaltrials.gov/show/NCT00957853

Link

https://clinicaltrials.gov/show/NCT00957853

Keywords

Versions (1)
  1. 6/11/20 6/11/20 -
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See clinicaltrials.gov

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June 11, 2020

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Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma NCT00957853

English

Eligibility Head and Neck Squamous Cell Carcinoma NCT00957853

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types ii and iii according to the world health organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. patients with skin squamous cell carcinomas of the head and neck region will also be included in this study.
Description

Squamous cell carcinoma of the head and neck | Exception Nasopharyngeal carcinoma Type | Excision of neoplasm Planned | Cutaneous Squamous Cell Carcinoma of the Head and Neck

Data type

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2931822
UMLS CUI [2,3]
C0332307
UMLS CUI [3,1]
C1299802
UMLS CUI [3,2]
C1301732
UMLS CUI [4]
C4524517
2. there is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. no anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. if a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization.
Description

Availability of Tumor tissue sample Paraffin Embedded | Biomarker Evaluation | Antineoplastic Therapy Absent | Tumor tissue sample Unavailable | Tumor Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [1,3]
C0085185
UMLS CUI [2,1]
C0005516
UMLS CUI [2,2]
C1261322
UMLS CUI [3,1]
C2346834
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0475358
UMLS CUI [4,2]
C0686905
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C0005558
3. prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months.
Description

Biological agents Targeted Therapy Epidermal Growth Factor Receptor

Data type

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C0034802
4. the patient has a fasting serum glucose < 130 mg/dl and hba1c < 7.0%. patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition.
Description

Serum fasting glucose measurement | Hemoglobin A1c measurement | Diabetes Mellitus Diet therapy Stable | Diabetes Mellitus Therapy Stable

Data type

boolean

Alias
UMLS CUI [1]
C0583334
UMLS CUI [2]
C0474680
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0012159
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0011849
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0205360
5. the patient has adequate renal function, defined by serum creatinine </= 1.5 * the institutional upper limit of normal (uln), or creatinine clearance >/=60 ml/min for patients with creatinine levels above the uln.
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
6. because the teratogenicity of cetuximab and imc-a12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
7. the patient is age >/= 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
8. the patient or the patient's legally authorized representative has the ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
9. eastern cooperative oncology group (ecog) performance status of 0-2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation.
Description

Antineoplastic Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003392
2. patients receiving concomitant radiation.
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
3. prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.
Description

Targeted Therapy Insulin-Like-Growth Factor I Receptor

Data type

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0140080
4. history of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or imc-a12.
Description

Allergic Reaction Compound Cetuximab Similar | Allergic Reaction Compound IMC-A12 Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0995188
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C3180625
UMLS CUI [2,4]
C2348205
5. pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded).
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
6. patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s).
Description

Illness Uncontrolled | Exacerbation Possible Due to Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C4086268
UMLS CUI [2,2]
C0332149
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0013230
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Similar models

Eligibility Head and Neck Squamous Cell Carcinoma NCT00957853

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck | Exception Nasopharyngeal carcinoma Type | Excision of neoplasm Planned | Cutaneous Squamous Cell Carcinoma of the Head and Neck
Item
1. histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types ii and iii according to the world health organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. patients with skin squamous cell carcinomas of the head and neck region will also be included in this study.
boolean
C1168401 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2931822 (UMLS CUI [2,2])
C0332307 (UMLS CUI [2,3])
C1299802 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C4524517 (UMLS CUI [4])
Availability of Tumor tissue sample Paraffin Embedded | Biomarker Evaluation | Antineoplastic Therapy Absent | Tumor tissue sample Unavailable | Tumor Biopsy
Item
2. there is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. no anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. if a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0085185 (UMLS CUI [1,3])
C0005516 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C2346834 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0475358 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C0027651 (UMLS CUI [5,1])
C0005558 (UMLS CUI [5,2])
Biological agents Targeted Therapy Epidermal Growth Factor Receptor
Item
3. prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was >/= 6 months.
boolean
C0005515 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
Serum fasting glucose measurement | Hemoglobin A1c measurement | Diabetes Mellitus Diet therapy Stable | Diabetes Mellitus Therapy Stable
Item
4. the patient has a fasting serum glucose < 130 mg/dl and hba1c < 7.0%. patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition.
boolean
C0583334 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C0012159 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0011849 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
Renal function | Creatinine measurement, serum
Item
5. the patient has adequate renal function, defined by serum creatinine </= 1.5 * the institutional upper limit of normal (uln), or creatinine clearance >/=60 ml/min for patients with creatinine levels above the uln.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
6. because the teratogenicity of cetuximab and imc-a12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Age
Item
7. the patient is age >/= 18 years.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
8. the patient or the patient's legally authorized representative has the ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
ECOG performance status
Item
9. eastern cooperative oncology group (ecog) performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antineoplastic Agents
Item
1. patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation.
boolean
C0003392 (UMLS CUI [1])
Therapeutic radiology procedure
Item
2. patients receiving concomitant radiation.
boolean
C1522449 (UMLS CUI [1])
Targeted Therapy Insulin-Like-Growth Factor I Receptor
Item
3. prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.
boolean
C2985566 (UMLS CUI [1,1])
C0140080 (UMLS CUI [1,2])
Allergic Reaction Compound Cetuximab Similar | Allergic Reaction Compound IMC-A12 Similar
Item
4. history of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or imc-a12.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0995188 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C3180625 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Pregnancy | Breast Feeding
Item
5. pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Illness Uncontrolled | Exacerbation Possible Due to Investigational New Drugs
Item
6. patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s).
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C4086268 (UMLS CUI [2,1])
C0332149 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
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