Trial Information

A Feasibility and Phase II Study of Proton Beam Radiotherapy for Patients With Cervical Cancer and FDG-PET Positive Para-aortic Lymph Nodes

PRIMARY OBJECTIVES:

I. To determine the feasibility of proton beam radiotherapy in patients with cervical cancer
and FDG-positive para-aortic lymph nodes.

SECONDARY OBJECTIVES:

I. To determine the incidence of acute toxicity of concurrent weekly cisplatin chemotherapy
in addition to pelvic and para-aortic irradiation using proton radiotherapy with
intracavitary brachytherapy in patients with carcinoma of the uterine cervix with pelvic and
para-aortic nodal involvement as demonstrated by FDG-PET.

II. To assess late complications from irradiation using proton beam therapy in place of
conventional photon beam therapy.

III. To compare the dose distribution to tumor and surrounding normal structures using DVHs
(Dose Volume Histograms) generated from the proton plan used to treat the patient and the
photon plan generated for comparison purposes.

IV. To evaluate whether there is a benefit to concurrent weekly cisplatin chemotherapy in
addition to pelvic and para-aortic proton beam radiotherapy with intracavitary brachytherapy
as evidenced by time to local failure, time to distant failure, time to other failures and
overall survival in patients with carcinoma of the uterine cervix with pelvic and
para-aortic nodal involvement as demonstrated by FDG-PET.

OUTLINE:

Patients undergo CT, MRI, or FDG-PET imaging scans for radiotherapy treatment planning.
Patients then undergo external proton beam radiotherapy once daily, 5 times per week, for up
to 9 weeks. Patients also receive cisplatin IV once weekly for 6 weeks during radiotherapy.
Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and
then annually for 3 years.