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GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine, With or Without Bevacizumab, as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II, Stage III, Stage IV, or Recurrent Stage I Epithelial Ovarian Cancer or Fallopian Tube Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8DA7C30C-FD52-1F06-E040-BB89AD430C14

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=8DA7C30C-FD52-1F06-E040-BB89AD430C14

Keywords:

Fallopian Tube Neoplasms

Clinical Trial

Eligibility Determination

Versions (4)

9/19/12 9/19/12 -
1/9/15 1/9/15 - Martin Dugas
1/9/15 1/9/15 - Martin Dugas
9/20/21 9/20/21 -

Uploaded on:

September 20, 2021

DOI:

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Creative Commons BY-NC 3.0 Legacy

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Fallopian Tube Cancer NCT01081262 Eligibility - GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) - 3128347v1.0

English 1

English

Details

No Instruction available.

1 forms

StudyEvent: GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube)
1. No Instruction available.

Tracking Information

GOG Institution Code

GOG Affiliate Code

Previous GOG #

Treating physician

Other Physician

Patient Hospital No.

Date of Birth

Patient Name, Last

Patient Name, First

Patient Name, Middle

Patient Social Security Number

Patient Zip Code

Country

Race

A Person Having Origins In Any Of The Black Racial Groups Of Africa. Terms Such As "haitian" Or "negro" Can Be Used In Addition To "black Or African American." (Black or African American)

A Person Having Origins In Any Of The Original Peoples Of North And South America (including Central America), And Who Maintains Tribal Affiliation Or Community Attachment. (American Indian or Alaska Native)

A Person Having Origins In Any Of The Original Peoples Of The Far East, Southeast Asia, Or The Indian Subcontinent Including, For Example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, The Philippine Islands, Thailand, And Vietnam. (Asian)

A Person Having Origins In Any Of The Original Peoples Of Europe, The Middle East, Or North Africa. (White)

Could Not Be Determined Or Unsure (Unknown)

Ethnicity

A Person Not Meeting The Definition For Hispanic Or Latino. (Not Hispanic or Latino)

A Person Of Mexican, Puerto Rican, Cuban, Central Or South American Or Other Spanish Culture Or Origin, Regardless Of Race. (Hispanic or Latino)

Could Not Be Determined Or Unsure (Unknown)

Method of Payment

Medicaid (Medicaid)

Medicaid And Medicare (Medicaid and Medicare)

Medicare (Medicare)

Medicare And Private Insurance (Medicare and Private Insurance)

8 more items in the detailed view.

Header

Did the patient sign an approved informed consent

Yes

Has HIPAA authorization been obtained?

Yes

Does the patient have a histologic diagnosis of mucinous adenocarcinoma of the ovary or Fallopian tube

Yes

What is the site of the disease

Ovary (Ovary)

Fallopian Tube (Fallopian tube)

Does the patient have either Stage II-IV disease (no brain metastasis) or recurrent Stage I disease (chemonaive)?

Stage Ii (Stage II)

Stage Iii (Stage III)

Stage Iv (Stage IV)

Recurrent (Recurrent (chemonaive))

If the patient is newly diagnosed, will protocol therapy begin within 6 weeks of primary debulking?

Yes (Yes)

No (No)

Recurrent Disease Not Applicable (Not Applicable - Recurrent disease)

If the patient is stage I (Recurrent), will protocol therapy begin within 14 days of randomization?

Yes (Yes)

No (No)

Primary Disease Or Disorder Not Applicable (Not Applicable - Primary disease)

Has the patient had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage?

Yes

Does this patient have measurable disease as defined by RECIST 1.1 criteria for assessing clinical response to treatment OR non-measurable disease? (see Section 8.0 in the protocol)

Measurable Disease (Measurable)

Non-measurable (Non-measurable)

Does the patient have measurable disease defined as any tumor lesion that can be accurately measured in at least one dimension with a minimum size of 1.0 cm by CT scan (CT scan slice thickness < 0.5 cm), 1.0 cm caliper measurement by clinical exam, 2.0 cm by chest X-ray, or 1.5 cm malignant, pathologically enlarged lymph node by CT scan?

Yes (Yes)

No (No)

Non-measurable (Not applicable - Non-Measurable)

What method of evaluation is used to obtain tumor measurements?

Ct Scan (CT scan)

Mri (MRI (NMR))

Vernier Caliper Measurement Physical Examination (Caliper measurement by clinical exam)

Chest X-ray (Chest x-ray)

What is the size of the largest residual lesion?

Less Than 0.1 Cm, No Gross Residual Disease (Less than 0.1 cm, no gross residual disease)

0.1 - 1.0cm, Optimal Gross Residual Disease (0.1 - 1.0cm, optimal gross residual disease)

>1.0 Cm, Suboptimal Gross Residual Disease (>1.0 cm, suboptimal gross residual disease)

Has the patient had a negative colonoscopy within one year of today?

Yes

Unnamed2

Date of Results (if more than one, enter earliest)

ANC (must be 1,500/mcl or greater)

WBC (must be 3,000 cells/mcl or greater)

Platelets (must be 100,000/mcl or greater)

1000/uL

Hemoglobin (Must be greater than or equal to 10 g/dl)

Is Serum Creatinine less than or equal to 1.5 X ULN

Yes

Is the Creatinine Clearance greater than 50 cc/min?

Yes

Is the bilirubin less than or equal to 1.5 X ULN

Yes

Are SGOT and Alkaline Phosphatase less than or equal to 2.5 times institutional ULN

Yes

Are sensory or motor neuropathy less than or equal to CTC Grade 1

Yes

Does the patient have one of the following: a urine dipstick for proteinuria less then 2+ OR If urine dipstick for proteinuria is greater then 2+, does the 24 hour urine demonstrate less then or equal to 1 g protein in 24 hours OR a urine protein-to-creatinine ratio (UPCR) less then or equal to 1.0 mg/dL?

Yes

Are PT and APTT less than or equal to 1.5 X ULN?

Yes

CA125 Laboratory upper limit of normal

Unnamed3

Will the patient have the following paramenters measured within 14 days prior to initiating protocol therapy (Toxicity Assessment, Coagulation parameters PT, APTT, CBC, Differential, Platelets, Electrolytes, BUN, Creatinine, Calcium, Magnesium, Phosphorus, UPCR or Urinalysis, Bilirubin, SGOT, Alkaline Phosphatase, Total protein albumin, CA-125)

Yes

Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical Exam, EKG, Radiographic tumor Measurement, Chest Imaging and Blood Pressure Measurement)

Yes

Has the patient met the pre-entry requirements as specified in section 7.0

Yes

Performance Status

Fully Active, Able To Carry On All Pre-disease Performance Without Restriction. (0)

Restricted In Physically Strenuous Activity But Ambulatory And Able To Carry Out Work Of A Light Or Sedentary Nature, E.g., Light Housework, Office Work. (1)

Ambulatory And Capable Of All Selfcare But Unable To Carry Out Any Work Activities. Up And About More Than 50% Of Waking Hours. (2)

Is the patient age 18 years or older

Yes

Does the patient have a life expectancy of greater than 3 months?

Yes

Does the patient have colon cancer or a history of colon cancer?

Yes

Does the patient have primary peritoneal carcinoma?

Yes

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

Yes

Has the patient ever received chemotherapy or radiotherapy for any gynecologic or colorectal cancer prior to enrollment?

Yes

Does the treating physician anticipate the need for major surgical procedure during the course of the study? (See Section 3.25)

Yes

Will the patient have any minor surgical procedures, fine needle aspirates or core biopsies within 7 days prior to the first date of Bevacizumab therapy?

Yes

Has the patient had surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for the fact that bevacizumab can be omitted from first cycle of chemotherapy)?

Yes

Does the patient have any evidence of wound disruption or impaired healing?

Yes

Does the patient have a history of abdominal fistula or perforation within the past 12 months?

Yes

Does the patient have a serious non-healing wound, ulcer, or bone fracture? (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.)

Yes

Does the patient have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies

Yes

Does the patient have mixed epithelial ovarian cancer histology?

Yes

Does the patient have a tumor of low malignant potential?

Yes

Does the patient have a history or evidence upon physical examination of CNS disease, including brain tumor, seizures not controlled with standard medical therapy or any brain metastases?

No (No)

Not Applicable (Not Applicable)

Yes (Yes)

Does the patient have uncontrolled hypertension defined as systolic pressure greater than 150mm Hg or diastolic greater than 100mm Hg?

Yes

Has the patient had myocardial infarction or unstable angina within 12 months of the first date of Bevacizumab therapy?

Yes

Using New York Heart Association (NYHA) guidelines, does the patient have Grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication?

Yes

Does the patient have Grade 1, Category 2 or greater, peripheral vascular disease?

Yes

Does the patient have a history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of Bevacizumab therapy?

Yes

Does the patient have a history of pulmonary embolism or deep vein thrombosis within the past 6 months?

Yes

Does the patient have a history of malabsorption or other conditions preventing oral treatment?

Yes

If the patient is of childbearing potential will she have a serum pregnancy test within 72 hours of starting protocol therapy and has she agreed to practice an effective form of birth control during study treatment and for six months after completion of treatment?

Yes (Yes)

No (No)

Not Applicable (Not Applicable)

Is the patient pregnant or nursing

Yes

Does the patient have acute hepatitis or active infection requiring parenteral antibiotics

Yes

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?

Yes

Is the patient taking warfarin?

Yes

Anticipated date treatment will start

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Fallopian Tube Cancer NCT01081262 Eligibility - GOG-0241: Fast Fact Sheet for Protocol 0241 (Ovary, Fallopian Tube) - 3128347v1.0

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