Cervical Adenocarcinoma Clinical Trial
Official title:
Utility of Preoperative FDG-PET/CT Scanning Prior to Primary Chemoradiation Therapy 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
This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer or high-risk endometrial cancer. Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer or endometrial cancer.
PRIMARY OBJECTIVES:
I. Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18
positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in
identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in
patients with locoregionally advanced cervical carcinoma.
II. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning
and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph
nodes in patients with high-risk endometrial cancer.
SECONDARY OBJECTIVES:
I. Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning
and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic
and abdominal lymph nodes combined in patients with locoregionally advanced cervical
carcinoma or high-risk endometrial cancer.
II. Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in
identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these
patients.
III. Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10
MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in
these patients.
IV. Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in
terms of size criteria in the abdomen and pelvis, in these patients.
V. Determine the percentage of patients with locoregionally advanced cervical cancer or
high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic
lymph nodes detected by PET/CT scanning.
VI. Determine the accuracy of MRI in determining the depth of myometrial invasion and
involvement of cervix in patients with high-risk endometrial cancer.
VII. Determine the complications associated with extraperitoneal or laparoscopic abdominal
and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer.
VIII. Determine the cause(s) of delay in the initiation of radiotherapy or interruption in
radiotherapy in patients with locoregionally advanced cervical cancer.
IX. Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally
advanced cervical carcinoma or high-risk endometrial cancer.
X. Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty
patients.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission
tomography (PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45
minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2. Patients undergo
extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal
lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic
disease prior to lymph node biopsy proceed directly to primary treatment. Patients with
cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.
After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months
for 2 years, and then every 6 months for 3 years.
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