Endometrial Cancer NCT00942357 Pre-Study - Fast Fact Sheet for Protocol 0258 (Endometrium) - 3244339v1.0 Tracking Information Header Did the patient sign an approved informed consent Yes
No
Is this the first patient to receive IMRT on this study (GOG 0258) from your Institution? Will the treatment plan for this first patient to be treated at your institution be digitally submitted to the ITC for processing in preparation for the rapid review? Has HIPAA authorization been obtained What is the site of the disease What is the cell type? What is the grade of the primary tumor Stage Positive Adnexa (For patients with Surgical Stage III disease, please indicate the areas of involvement at least one must be Yes - answer Yes to all that apply:) Tumor involves the serosa Positive pelvic nodes Positive para-aortic nodes Vaginal involvement Parametrial involvement Does the patient have FIGO 2009 Surgical Stage I or II endometrial clear cell or serous carcinoma with positive peritoneal cytology? Has the patient had a hysterectomy and bilateral salpingo-oophorectomy? Yes
No
Does the patient have residual tumor after surgery (any single site) exceeding 2 cm in maximum dimension? Yes
No
What type of external beam radiation is planned in the event that Regimen I is assigned to the patient? Has the treating Institution been credentialed for IMRT by the Radiological Physics Center (RPC) at M.D. Anderson Cancer Center? Is the Serum Creatinine less than or equal to institutional ULN? Yes
No
Is the bilirubin less than or equal to 1.5 x ULN Yes
No
Are the SGOT, SGPT and Alkaline Phosphatase less than or equal to 2.5 X ULN? Yes
No
Will the patient have the following parameters measured within 14 days prior to initiating protocol therapy (HGB or HCT, ANC, Differential, Platelets, Creatinine, Bilirubin, SGOT, SGPT, Alkaline Phosphatase, Urinalysis and Quality of Life Assessment) Yes
No
Will the patient have the following parameters measured within 28 days prior to initiating protocol therapy (History and Physical Exam, Toxicity Assessment, Pelvic Examination, Chest X-Ray, Abdominal/Pelvi CT and if required a Chest CT scan) Yes
No
Do the testing values/results meet the eligibility criteria as specified in Section 3.1? Yes
No
Has the patient met the pre-entry requirements as specified in section 7.0 Yes
No
Performance Status Is the patient age 18 years or older Yes
No
Does the patient have a diagnosis of carcinosarcoma? Yes
No
Does the patient have recurrent endometrial cancer Yes
No
Has the patient received prior radiotherapy to any portion of the abdominal cavity or pelvis Yes
No
Does the patient have a history of invasive cancer other than non-melanoma skin cancer that has been active within the last 5 years? Yes
No
Has the patient had previous cancer treatment which contraindicates this protocol therapy Yes
No
Does the patient have a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy? Yes
No
Does the patient have an estimated survival of less than 3 months? Yes
No
Does the patent have FIGO 2009 Stage IVB endometrial cancer? Yes
No
Does the patient have a history of myocardial infarction, unstable angina or uncontrolled arrythmia within 3 months of enrollment? Yes
No
Does the patient have parenchymal liver metastases? Yes
No
Has patient received prior chemotherapy for endometrial cancer? Yes
No
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