Description:

NSABP PROTOCOL C-08: REGISTRATION FORM Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer NCT00096278 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6865F-B506-428D-E034-0003BA12F5E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D7F6865F-B506-428D-E034-0003BA12F5E7

Keywords:
Versions (4) ▾
  1. 8/27/12
  2. 1/9/15
  3. 3/22/15
  4. 9/20/21
Uploaded on:

September 20, 2021

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License:
Creative Commons BY-NC 3.0 Legacy
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Colon cancer (NSABP C-08 NCT00096278)

Refer to patient entry guidelines in the Members' Area of the NSABP Web site.

  1. StudyEvent: NSABP PROTOCOL C-08: REGISTRATION FORM
    1. Refer to patient entry guidelines in the Members' Area of the NSABP Web site.
Header
Race (more than one may be marked)
Method of Payment (mark primary method only)
Ethnicity
Country of Residence (if not USA)
Performance Status
Patient characteristics
cm
Kg
Patient Gender
Menopausal status (Females only)
mg/dL
mg/dL
g/24 hours
Your blood and tissue samples may be kept by the NSABP for use in this study and future research to learn about, prevent, detect, or treat cancer.
Your blood and tissue samples may be used for research about other health problems (for example: causes of heart disease, osteoporosis, diabetes).
Your study doctor (or someone he or she chooses) may contact you in the future to ask you to take part in more research.
Your blood samples may be collected and sent to Genetech, Inc. for bevacizumab antibody testing.
C-08 Eligibility Checklist
Does the patient have psychiatric or addictive disorders that would preclude the patient from meeting the study requirements?
Has the patient authorized the release of Protected Health Information to the NSABP?
Has the patient consented to participate in this study and signed and dated an approved consent form?
Does the patient have a colon tumor that is other than adenocarcinoma?
Were there any isolated, distant, or non-contiguous intra-abdominal metastases (other than regional lymph nodes)?
Did the patient have an en bloc complete gross resection of tumor by open laparotomy or laparoscopically-assisted colectomy, i.e., curative resection?
Has the patient received any systemic therapy or surgery (other than a decompressive colostomy or en bloc resection of tumor) for the current colon cancer?
Is the distal extent of the lowest lying colon tumor greater or equal to 12 cm from the anal verge?
Does the patient have a histologically confirmed Stage II (T3, 4 N0 M0) or Stage III (any T N1,2 M0) tumor?
Is there postoperative evidence of adequate hepatic function as described in the protocol?
Are the postoperative absolute granulocyte count and platelet count within the criteria set by the protocol?
Is the patient's PT (INR) within the criteria set by the protocol?
Does the patient have significant peripheral neuropathy defined in the NCI CTCAE v3.0 as a grade 2 or greater neurosensory or neuromotor toxicity?
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of entry, or is there anticipation of a need for major surgical procedure during the course of the study?
Does the patient have uncontrolled hypertension?
Has the patient had any prior malignancies in the past 5 years other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the colon or rectum, or carcinoma in situ of the cervix that has been effectively treated?
Does the patient have Class III or Class IV cardiac disease or symptomatic arrhythmia
Does the patient have a history of myocardial infarction or unstable angina within the past 12 months
Does the patient have a prior history of TIA or CVA
Does the patient have a history of symptomatic peripheral vascular disease
Does the patient have a history of arterial thrombotic event within the past 12 months
Does the patient have a serious non-healing wound, skin ulcers or bone fracture?
Does the patient have active gastroduodenal ulcer(s) determined by endoscopy to be active?
Does the patient meet all other eligibility criteria?
In the opinion of the investigator, is the patient eligible?

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