TILITY OF PREOPERATIVE FDG-PET/CT SCANNING PRIOR TO PRIMARY CHEMORADIATIONTHERAPY TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA >=;4 CM, IIB-IVA) OR ENDOMETRIUM (GRADE 3 ENDOMETRIOID ENDOMETRIAL CARCINOMA; SEROUS PAPILLARY CARCINOMA, CLEAR CELL CARCINOMA, OR CARCINOSARCOMA (ANY GRADE); AND GRADE 1 OR 2 ENDOMETRIOID ENDOMETRIAL CARCINOMA WITH CERVICAL STROMAL INVOLVEMENT OVERT IN CLINICAL EXAMINATION OR CONFIRMED BY ENDOCERVICAL CURETTAGE)
- Conditions
- PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA >=4 CM, IIB-IVA) OR ENDOMETRIUM (GRADE 3 ENDOMETRIOID ENDOMETRIAL CARCINOMASEROUS PAPILLARY CARCINOMA, CLEAR CELL CARCINOMA, OR CARCINOSARCOMA (ANY GRADE)AND GRADE 1 OR 2 ENDOMETRIOID ENDOMETRIAL CARCINOMA WITH CERVICAL STROMAL INVOLVEMENT OVERT IN CLINICAL EXAMINATION OR CONFIRMED BY ENDOCERVICAL CURETTAGE)
- Registration Number
- JPRN-UMIN000006787
- Lead Sponsor
- ational Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 380
Not provided
1) Patients who had a prior pelvic or abdominal lymphadenectomy performed for any reason. 2) Patients who have received prior pelvic radiation therapy for any reason. 3) Patients with circumstances that will not permit completion of the imaging studies or required follow up. 4) Patients with renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, which would require modification of the lymphadenectomy. 5) Patients with a history of anaphylactic or life-threatening allergic reactions to any contrast media. 6) Patients who are pregnant or lactating or who suspect they might be pregnant. 7) GOG PS: 3 or 4 8) Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy. 9) Patients with a history of cirrhosis. 10) Patients with poorly controlled, insulin-dependent diabetes (fasting blood glucose level >200 mg/dL). 11) Patients weighing greater than that allowable by the PET/CT scanner. Cervical Cancer Only: 1) Patients with recurrent invasive carcinoma of the uterine cervix regardless of previous treatment. 2) Patients who have known metastases to lungs, scalene lymph nodes, or metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis. 3) Patients with any stage of cervical cancer other than IB2, IIA >=4cm, and IIB-IVA. Endometrial Cancer Only: 1) Patients with recurrent invasive carcinoma of the uterus regardless of previous treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning
- Secondary Outcome Measures
Name Time Method