Description:

N0949 Registration Form and Eligibility Checklist Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9156A820-0337-BDA0-E040-BB89AD435144

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9156A820-0337-BDA0-E040-BB89AD435144

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  1. 12/18/14
  2. 9/20/21
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Cognitive/Functional Effects NCT01279681 Eligibility - N0949 Registration Form and Eligibility Checklist - 3143440v1.0

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  1. StudyEvent: N0949 Registration Form and Eligibility Checklist
    1. No Instruction available.
Required Characteristics
Age >= 70 years (age 70-74 years limited to no greater than 25% of the whole study population and eligibility will be modified at the time this benchmark is reached)
Patients must have metastatic colorectal cancer that has been histologically or cytologically confirmed. Confirmation may be from either the primary tumor or a metastasis
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1 or 2
ECOG Performance Status
The following laboratory values obtained <=14 days prior to randomization
Absolute neutrophil count (ANC) >=1,500/mm^3
Peripheral platelet count (PLT) >=100,000/mm^3
Hemoglobin >9.0 g/dL (HgB)
Total bilirubin <=1.5 x upper limit of normal (ULN)
Aspartate transaminase (AST) <=2.5 x ULN (<=5 x ULN for patients with liver involvement)
Alkaline phosphatase <=3 x upper limit of normal (ULN) (<=5 x ULN for patients with liver involvement)
Is there liver involvement (This question may be answered yes or no.)
Is there liver involvement (This question may be answered yes or no.)
Creatinine <= 1.5 x ULN
INR <1.5 x upper limit of normal (ULN) unless patients are receiving anti-coagulation therapy. Patients receiving prophylactic anti-coagulation therapy with an agent such as warfarin or heparin are allowed to participate if INR <=3.0
Patient receiving anti-coagulation therapy (This question may be answered yes or no.)
UPC ratio <1 or urine dipstick <2+ (NOTE: Urine protein must be screen by urine analysis for Urine Protein Creatinine UPC ratio or by dipstick. For UPC ratio >=1.0 or urine dipstick >=2+, 24-hour urine protein must be obtained and the level should be <1000 mg)
Life expectancy >=3 months
Ability to complete questionnaire(s) by themselves or with assistance
Provide informed written consent
Willing to provide mandatory blood samples for correlative research purposes (see Sections 6.0 and 14.0)
Exclusion Criteria - All Responses In Section Below Must Be "no."
The following because this study involves agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: Men of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety and adverse events of the prescribed regimens
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive with CD4<100 cells/uL
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy <=3 years prior to randomization. EXCEPTIONS: Non-melanotic. Skin cancer or carcinoma-in-situ of the cervix. (NOTE: If there is a history of prior malignancy, patient must not be receiving other specific treatment other than hormonal therapy for this prior cancer.)
Prior chemotherapy, radiation therapy, immunotherapy, or biologic therapy for recurrent or metastatic colorectal cancer (NOTE: Prior chemotherapy or radiotherapy is permitted if they had been administered as adjuvant or neoadjuvant therapy and a complete surgical resection of the original colorectal cancer had been achieved.)
Progressive disease <=12 months of completing oxaliplatin-containing adjuvant therapy
Prior radiation to >30% of the bone marrow at any time
Calculated creatinine clearance >=60 mL/minute (NOTE: If calculated creatinine clearance does not meet eligibility requirement, a 24-hour urine can be collected for a creatinine clearance, and the patient can be enrolled if measured creatinine clearance >=60 mL/minute.)
Known central nervous system or brain metastasis that are either symptomatic or untreated (Note: If a patient has a resection of the metastasis and is no longer symptomatic, the patient is eligible for the study. NOTE: Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.)
New York Heart Association (NYHA) classification III or IV congestive heart failure
Inadequately controlled hypertension (systolic blood pressure of >150 mmHg or diastolic pressure >100 mmHg on anti-hypertensive medication)
Core biopsy or other minor surgical procedures <=7 days prior to randomization
Active or recent Hemoptysis (>=1/2 teaspoon of bright red blood per episode) <=30 days prior to randomization
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess <=6 months prior to randomization
Serious, non-healing wound, active ulcer, or untreated bone fracture (NOTE: Patients with fractures secondary to metastatic disease are eligible after appropriate radiotherapy.)
History of hypertensive crisis or hypertensive encephalopathy
Major surgical procedures, open biopsy or significant traumatic injury <=28 days prior to randomization or anticipation of need for elective or planned major surgical procedure during the course of the study
Patient has experienced any arterial thromboembolic events, included but not limited to myocardial infarction, stroke, transient ischemic attack (TIA), cerebrovascular accident, or unstable angina <=6 months prior to randomization or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis <=6 months prior to randomization
Evidence or history of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation), any hemorrhage/bleeding event >Grade 3 <=4 weeks prior to randomization. Patients with full-dose anticoagulants are eligible provided the patient has been on a stable dose, at least 2 weeks, of low molecular weight heparin or warfarin and has an INR range 2-3. Aspirin doses >325 daily are not allowed.
Known hypersensitivity to any of the components of 5-fluorouracil/leucovorin, capecitabine, oxaliplatin, or bevacizumab
Clinically significant peripheral neuropathy at the time of randomization (defined in the NCI COmmon Terminology Criteria for Adverse Event [CTCAE} v4.0 as >=2 neurosensory or neuromotor toxicity)
Pre-registration Check
Consent form signed and dated
Authorization for use and disclosure of protected health information signed and dated (If not a USA institution check NA)
A mandatory correlative research component for blood is part of this study, the patient will be automatically registered onto this component (see Sections 3.18 and 14.0)
Treatment on this protocol must commence at the accruing membership under the supervision of a CTSU, NCCTG, or CALGB member physician
Treatment cannot begin prior to randomization and must begin <=14 days and after submission of Physician Fluoropyrimidine Treatment Decision Form (NOTE: The Physician Fluoropyrimidine Treatment Decision Form must be submitted <=7 days after patient randomization.)
Pretreatment tests/procedures (see Section 4.0) must be completed <=14 days prior to randomization (see Section 4.0)
All required baseline symptoms (see Section 10.3) must be documented and graded
Blood draw kit is available on site
Patient Questionnaire Booklets and Research Team Questionnaire Booklets are available on site; copies are not acceptable for this submission
Ran
Patient has given permission to give his/her tissue sample(s) to NCCTG for research testing planned as part of this study
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of randomization, the following will also be recorded:)
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Patient has given NCCTG permission to give his/her stored sample(s) for use in future research to outside researchers
Stratification Factors (used Fo Randomization To Arms A-b)
Age (years)
ECOG Performance status (PS)
Number of metastatic sites

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