Trial Information

A Phase III Randomized Trial of FDG-PET in the Management of Advanced Cervical Cancer With Enlarged Pelvic Lymph Node on MRI Image

Concurrent radiotherapy and chemotherapy is the standard treatment for locally advanced
cervical cancer. The radiation field should be adjusted according to the extension of
disease, especially the presence of metastatic lymph nodes. At present, CT/ MRI have been
applied for the detection of enlarged lymph nodes, as the reference of radiation field.
However, not infrequently, a small-sized lymph node on CT/MRI may be metastatic while an
enlarged node may be resulted from reactive hyperplasia.

Unlike CT/ MRI, 18F-FDG positron emission tomography (FDG-PET) provides a novel means of
imaging malignancy and could differentiate benign tumor from malignancy by functional
assessment. Recent studies demonstrated higher accuracy of FDG-PET scan for the evaluation
of metastasis in patients with several types of cancers when compared with CT scan or MRI.
But, only a few reports concerned the usefulness of FDG-PET in cervical carcinoma.

Our hypothesis is that adding FGD-PET study to a thorough MRI can provide better staging,
especially on the identification of metastatic pelvic or para-aortic lymph nodes. In
addition, this whole body scan may also detect occult distant metastases that are not
detectable by standard workup. Our initial result of a phase II study---"A Preliminary
Report of Using FDG-PET to Detect Extra-pelvic Lesions in Cervical Cancer Patients with
Enlarged Pelvic Lymph Nodes Shown on MRI/CT Images” indicated that FDG-PET helped to detect
occult or small metastatic lesions, and resulted in a change of radiation treatment plan.
Nevertheless, for high-risk group patients, distant metastasis still occurred in a short
period after treatment. Therefore, it is also our question that whether the enhancement of
detection provided by FDG-PET can be translated into improvement of final overall survival.

To answer these questions, the Gynecologic Oncology Study Group in Chang Gung Memorial
Hospital has designed a phase III clinical study. Patients with enlarged pelvic lymph node
detected on MRI imaging are enrolled and randomized into two groups before the initiation of
concurrent chemoradiation.