Description:

GOG-0240: Fast Fact Sheet for Protocol 0240 (Cervix) NCT00803062 Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=79B3F748-B0A4-3597-E040-BB89AD433B56

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=79B3F748-B0A4-3597-E040-BB89AD433B56

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Versions (5) ▾
  1. 8/27/12
  2. 1/9/15
  3. 1/9/15
  4. 6/29/15
  5. 9/20/21
Uploaded on:

September 20, 2021

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License:
Creative Commons BY-NC 3.0 Legacy
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GOG-0240: Fast Fact Sheet for Protocol 0240 (Cervix) NCT00803062

No Instruction available.

  1. StudyEvent: GOG-0240: Fast Fact Sheet for Protocol 0240 (Cervix)
    1. No Instruction available.
Patient demographics
Race
Ethnicity
Method of Payment
Miscellaneous Patient Information
Did the patient sign an approved informed consent
Has HIPAA authorization been obtained
What is the primary disease site
What is the cell type
What was the grade of the primary tumor
Select statement that most appropriately describes the status of the disease
How was the Stage IV disease, recurrence or persistence confirmed
Performance Status
Does the patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension
Is the measurable disease >= 20 mm when measured by conventional techniques, including palpation, plain X-ray, CT and MRI or >=10mm when measured by spiral CT
What method of evaluation is used to obtain tumor measurements
What additional method of evaluation is used to obtain tumor measurements (if any)
If measurable lesion is less than 30 mm or if treating physician determines it to be clinically indicated, has a confirmatory biopsy been done
Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST
Is the measurable disease in a previously irradiated field
Does the patient have disease in an irradiated field as the only site of measurable disease (If yes,)
Has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment (If yes,)
Has the patient recovered from the effects of recent surgery, radiotherapy or chemo-radiotherapy
If the patient received radiation therapy alone, have at least 3 weeks elapsed since the last treatment day
If the patient had a major surgical procedure, have at least 6 weeks elapsed from the time of the procedure
If the patient received chemo-radiation, have at least 6 weeks elapsed since the last administered of chemo-radiotherapy
Did the patient receive prior platinum therapy as a radiation sensitizer
Has the patient received concurrent paclitaxel and/or concurrent topotecan with radiation
Are any of the target lesions in a previously irradiated field
Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (CBC, Differential, Platelets, Serum Creatinine, Urinanalysis, Bilirubin, DGOT, Alkaline Phosphatase, Electrolytes, BUN, Calcium, Magnesium, Phosphate and Albumin)
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical Exam, Toxicity Assessment, CA-125, Imaging of chest, pelvis and abdomen, EKG and Tumor Measurements radiographic or clinical)
Is the patient free of active infection requiring antibiotics
Has the patient completed a baseline Quality of Life assessment and Smoking Questionnaire
Is the patient's cancer amenable to curative treatment with surgery or radiation therapy
Does the patient have craniospinal metastasis
Does the patient have bilateral hydronephrosis which cannot be alleviated by stenting or percutaneous drainage
If the patient has had a prior invasive malignancy (except non-melanoma skin cancer), has she had any evidence of disease within the last 5 years or does the prior malignancy treatment contraindicate the current protocol therapy
Does patient have a concomitant malignancy other than non-melanoma skin cancer
Has the patient received a trial of chemotherapy that was not in combination with radiation therapy
Does the patient have a serious non-healing wound, ulcer, or bone fracture
Does the patient have active bleeding or pathologic conditions that carry high risk of bleeding such as known bleeding disorder, coagulopathy or tumor involving major vessels
Does the patient have a history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study
Does the patient have uncontrolled hypertension defined as systolic pressure greater than 150mm Hg or diastolic greater than 90mm Hg
Has the patient had unstable angina or a myocardial infarction within the past six months
Does the patient have New York Heart Association Grade II or greater congestive heart failure
Does the patient have serious cardiac arrhythmia requiring medication
Does the patient have CTCAE Grade 2 or greater peripheral vascular disease
Does the patient have pre-existing Grade 2 or greater peripheral neuropathy
Does the patient have a history of CVA within the last six months
Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to the first date of Bevacizumab therapy
Is a major surgical procedure anticipated for this patient during the course of this study
Has the patient had a core biopsy within 7 days prior to randomization
Is the patient pregnant or nursing
If patient is of childbearing potential, has she agreed to use contraceptive measures during study therapy and for at least 6 months after completion of Bevacizumab therapy
Has the patient received prior therapy with any anti-VEGF drug, including Bevacizumab
Does the patient have clinical symptoms or signs of gastrointestinal obstruction and require parenteral hydration and/or nutrition
Does the patient have a medical history or condition not otherwise previously specified which in the opinion of the investigator should exclude her from participating in this study
Lab Results
1000/uL
Is the Serum Creatinine less than or equal to ULN (CTCAE v3.0 Grade 1)
Is the bilirubin less than or equal to 1.5 X ULN (CTCAE v3.0 Grade 1)
Are SGOT and Alkaline Phosphatase less than or equal to 2.5 times institutional ULN
Is the PT INR less than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and the PTT less than 1.2 times the Upper Limit of Normal
Does the patient have a urine protein-to-creatinine ratio (UPCR) less than 1.0 mg/dL
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