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

Phase 3
Open (Enrolling)
Cervical Cancer

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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.

Inclusion Criteria:

- Newly diagnosed cervical cancer clinical stage FIGO I –IVA

- Histologically proven cervical carcinoma (including histologic types of squamous
cell carcinoma, adenocarcinoma, adenosquamous carcinoma, adenoid cystic carcinoma,
lymphoepithelial-like carcinoma and malignant mixed mullerian tumor)

- Presence of at least one enlarged pelvic lymph node (>=1.0 cm in its maximal
dimension), or group of small pelvic nodes (size <1 cm), and without suspicious
para-aortic lymph node metastasis or any lesion outside the pelvis by conventional
MRI or CT study

- Karnofsky performance scale >=60

- Available for concurrent chemoradiation therapy of curative intent

Exclusion Criteria:

- Cervical tumor with histologic diagnosis of verrucous carcinoma or small cell

- Other serious illness or medical condition which would interfere with extended field
irradiation or chemotherapy

- Past or current history of malignancy, except for curatively treated non-melanoma
skin cancer

- Patients not suitable to receive PET study either by technical or psychological

- Patients who are judged to be noncompliant to treatment or not accessible for follow

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

The difference of disease-free-survival and overall-survival with/ without FDG-PET at two years after treatment

Principal Investigator

Chien-Sheng Tsai, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology, Chang Gung Memorial Hospital


Taiwan: Department of Health

Study ID:




Start Date:

January 2002

Completion Date:

December 2007

Related Keywords:

  • Cervical Cancer
  • Cervical cancer
  • Lymph node metastasis
  • Radiotherapy
  • Chemotherapy
  • Uterine Cervical Neoplasms