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GOG-0265: Fast Fact Sheet for Protocol 0265 (Cervix) Vaccine Therapy in Treating Patients With Persistent or Recurrent Cervical Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A9974A7-54D8-82CF-E040-BB89AD431753

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9A9974A7-54D8-82CF-E040-BB89AD431753

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  1. 8/27/12
  2. 1/9/15
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January 9, 2015

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Creative Commons BY-NC 3.0 Legacy
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Cervical Cancer NCT01266460 Pre-Study - GOG-0265: Fast Fact Sheet for Protocol 0265 (Cervix) - 3185379v1.0

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  1. StudyEvent: GOG-0265: Fast Fact Sheet for Protocol 0265 (Cervix)
    1. No Instruction available.
Tracking Information
Header
Did the patient sign an approved informed consent
Has HIPAA authorization been obtained
Is the patient eligible for a higher priority GOG protocol
What is the primary disease site
What is the cell type?
What was the grade of the primary tumor
Is the disease recurrent or persistent with documented progression? Which one? (disease not amenable to curative therapy)
How was it established to be recurrent or persistent?
Does patient have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) using RECIST 1.1 criteria?
What method of evaluation is used to obtain tumor measurements?
Is the measurable disease > or = 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or > or = 20 mm when measured by chest x-ray or lymph nodes > or = 15 mm in short axis when measured by CT or MRI?
Does the patient have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1?
Is the measurable disease in a previously irradiated field?
If yes, does the patient have disease in an irradiated field as the only site of measurable disease and has progression been documented or a biopsy obtained to confirm persistent disease at least 90 days following completion of radiation treatment?
Has the patient recovered from the effects of recent surgery, radiotherapy or chemotherapy?
Is the patient free of active infection requiring antibiotics?
Has any hormonal therapy directed at the malignant tumor been discontinued at least one week prior to registration? (continuation of hormone replacement therapy is permitted)
Has all prior therapy directed at the malignant tumor, including immunologic agents, been discontinued for at least three weeks prior to registration?
How many prior cytotoxic chemotherapy regimens has the patient received? (Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is not counted as a systemic chemotherapy regimen)
Performance Status (Patients who have received one prior regimen must have a performance status of 0, 1 or 2 - patients who have received two prior regimens must have a performance status of 0 or 1)
Has the patient received any non-cytotoxic chemotherapy for management of recurrent or persistent disease
Platelets greater than or equal to 100,000/mcl?
ANC greater than or equal to 1,500/mcl?
Is the Lymphocyte count greater than or equal to 700/mcl?
Is the creatinine less than or equal to 1.5 X ULN
Is the bilirubin less than or equal to 1.5 x ULN
Is the SGOT, SGPT, and GGT less than or equal to 1.5 x ULN?
Is the alkaline phosphatase less than or equal to 2.5 x ULN?
Is Neuropathy (sensory and motor) less than or equal to CTCAE grade 1?
Has the patient met the pre-entry requirements as specified in section 7.0
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical, Performance Status, Clinical Tumor Measurements, Vital Signs, Chest Imaging and Radiographic Tumor Measurement)
Will the patient have the following parameters measured within 14 days prior to initiating protocol therapy (Toxicity Assessment, CBC/Differential/Platelets, Electolytes, BUN, Creatinine, Calcium, Magnesium, Phosphates, Urinalysis, Bilirubin, SGOT, SGPT, GGT and Alkaline Phosphatase)
If the patient has childbearing potential, has she had a negative serum pregnancy test performed 48 hours prior to study entry?
Has the patient agreed to practice an effective form of contraception during protocol therapy and for at least two months following completion of protocol therapy?
Is the patient pregnant or nursing?
Is the patient under age 18?
Does the patient have the ability to swallow oral medication
Has the patient received prior therapy with ADXS11-001?
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 3 years?
Has the patient had previous cancer treatment which contraindicates this protocol therapy
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of cervical cancer within the last three years? (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 other than for the treatment of cervical cancer within the last three years? (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)
Is the patient allergic to both penicillin and trimethoprim-sulfa (including history of rash or anaphalaxis)?
Is the patient allergic to naproxen?
Is the patient currently receiving antibiotics?
Is the patient currently receiving steroids or has she received steroids within the past four weeks (topical corticosteroids and occasional inhaled corticosteroids are allowed)?
Has 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 requirement?
Does the patient have liver cirrhosis or any other impaired hepatic function as determined by serum enzymes?
Is the patient known to be seropositive for HIV even if liver function studies are in eligible range?
Is the patient known to be seropositive for active hepatitis even if liver function studies are in the eligible range?
Does the patient have a prior history of a splenectomy and/or sickle cell trait/disease?
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