Description:

GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal) Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=893B4E4E-209D-97F3-E040-BB89AD4371DB

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=893B4E4E-209D-97F3-E040-BB89AD4371DB

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Versions (5) ▾
  1. 9/19/12
  2. 1/9/15
  3. 1/9/15
  4. 1/9/15
  5. 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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Fallopian Tube Cancer NCT01167712 Pre-Study - GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal) - 3110638v1.0

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  1. StudyEvent: GOG-0262: Fast Fact Sheet for Protocol 0262 (Ovary, Fallopian Tube, Primary Peritoneal)
    1. No Instruction available.
Tracking Information
Race
Ethnicity
Method of Payment
Header
Did the patient sign an approved informed consent
Has HIPAA authorization been obtained?
What is the site of the disease
What is the stage/residual disease status
If Stage IV, how was the stage documented
Is the patient eligible for a higher priority GOG protocol (for example GOG-0252)
What was the grade of the primary tumor
Does this patient have measurable disease as defined by RECIST criteria for assessing clinical response to treatment OR non-measurable disease (see Section 8.0 in the protocol)
What is the cell type
Does the patient have a current diagnosis of borderline epithelial ovarian tumor or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only
Is the patient going to receive neo-adjuvant chemotherapy with interval cytoreductive surgery
Was the required core biopsy done
Does the patient have documentation of at least stage II disease acquired via imaging or surgery (without attempt at cytoreduction)
Has the patient had abdominal surgery with appropriate tissue available for histologic evaluation and maximum tumor debulking
Has the patient had another invasive malignancy (other than non-melanoma of the skin, localized cancer of the breast, head and neck or skin) diagnosed, present or recur within the past 5 years
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis (Prior radiation for localized cancer of the breast, head and neck or skin is permitted as long as it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease )
Has the patient received prior chemotherapy for any abdominal or pelvic tumor including neo-adjuvant chemotherapy for their ovarian, primary peritoneal or Fallopian tube cancer (Prior adjuvant chemotherapy for localized breast cancer is permitted provided it was completed more than 3 years prior to registration and the patient remains free of recurrent or metastatic disease.)
Has the patient had previous cancer treatment which contraindicates this protocol therapy
If the patient has a synchronous primary endometrial cancer or past history of endometrial cancer, is it more advanced than Stage I-B OR with greater than superficial myometrial invasion with vascular or lymphatic invasion OR poorly differentiated subtypes including papillary serous, clear cell or other FIGO Grade 3 lesions
Has the patient received any targeted therapy (including, but not limited to vaccines, antibodies or tyrosine kinase inhibitors) or hormonal therapy for management of their ovarian, Fallopian tube or peritoneal primary carcinoma
Performance Status
Unnamed2
1000/uL
Is the bilirubin less than or equal to 1.5 X ULN
Is the SGOT less than or equal to 3 X ULN
Is the alkaline phosphatase less than or equal to 2.5 X ULN
Is Serum Creatinine less than or equal to 1.5 X ULN
Are sensory or motor neuropathy less than or equal to CTC Grade 1
Unnamed3
Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (CBC, Differential, Platelets, Serum Creatinine, Bilirubin, SGOT, Alkaline Phosphatase, Calcium, Phosphorus, Magnesium, Urinalysis, Toxicity Assessment, Serum Pregnancy test if childbearing potential exists)
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical Exam, CA-125, Chest X-Ray, EKG and Radiographic Disease Assessment)
If the patient has a history of hearing loss, has an audiogram been performed
Does the patient have acute hepatitis or active infection requiring parenteral antibiotics
Has the patient had a myocardial infarction, unstable angina or a history of CVA within the last 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 (This does not include asymptomatic, atrial fibrillation with controlled ventricular rate)
Is the patient pregnant or breastfeeding
Is the patient age 18 years or older
Has the patient received prior therapy with any anti-VEGF drug, including Bevacizumab
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
Eligibility 4
Has the patient elected to receive concurrent or consolidation bevacizumab?
Has the pre-treatment blood pressure been recorded
Are the pre-treatment Urine Protein-Creatine Ratio (UPCR) results available
Is the urine protein-creatinine ratio (UPCR) less than 1.0
Are the pre-treatment PT/PT INR/PTT results available
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
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy: Blood Pressure
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 serious non-healing wound, ulcer or bone fracture? (This includes history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days. Patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound re-examinations - See Section 7.1 in the protocol.)
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 CTCAE Grade 2 or greater peripheral vascular disease
Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies or a known allergy to cremophor or Polysorbate 80?
Has the patient had a major surgical procedure, open biopsy or significant traumatic injury within 28 days of treatment start date of Bevacizumab therapy (cycle 2)?
Is a major surgical procedure anticipated for this patient during the course of this study
Will the patient have any tissue biopsy, such as a core biopsy, within 7 days prior to treatment start date of Bevacizumab therapy (cycle 2)?
Does the patient have clinical symptoms or signs of gastrointestinal obstruction and require parenteral hydration or nutrition?
Does the patient have metastatic tumor in the parenchyma of the liver or lungs with proximity to large vessels which could make the patient at high risk of lethal hemorrhage during treatment with Bevacizumab (i.e. hemoptysis, liver rupture)?
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 pre-treatment incision check been completed?
Is your site accredited to participate in the imaging component of this study, ACRIN 6695
If your site is accredited, did the patient consent to participate in the imaging component of this study, ACRIN 6695
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