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Clinical Trials/JPRN-UMIN000006787
JPRN-UMIN000006787
Completed
Phase 2

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) - UTILITY OF PREOPERATIVE FDG-PET/CT SCANNING TO DETECT RETROPERITONEAL LYMPH NODE METASTASIS IN PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX AND HIGH RISK ENDOMETRIAL CANCER

ational Cancer Institute0 sites380 target enrollmentDecember 1, 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
PATIENTS WITH LOCOREGIONALLY ADVANCED CARCINOMA OF THE CERVIX (IB2, IIA &gt
Sponsor
ational Cancer Institute
Enrollment
380
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 1, 2011
End Date
October 3, 2016
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
ational Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Not specified

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