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


Phase 2
18 Years
N/A
Not Enrolling
Female
Cervical Cancer, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage IVA Cervical Cancer

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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.

Inclusion Criteria


Inclusion

- Patients must have histologically documented carcinoma of the uterine cervix

- FIGO Stage IB to IVA

- Patients must have no distant metastases apart from positive lymph nodes by FDG PET

- Patients must have a Karnofsky Performance Status of >= 60

- Treatment plan includes cisplatin and patient has no medical contraindications to the
administration of cisplatin

- Adequate bone marrow function: WBC >= 3000/mm^3; platelets >= 75,000 mm^3

- Adequate renal function: creatinine =< 2.0 mg/dl (urinary diversion is permitted to
improve renal function)

- Patients must have bilirubin =< 1.5 mg/dl

- Ability to understand and the willingness to sign a written informed consent document

Exclusion

- FDG PET Scan evidence of distant disease

- No prior surgery for treatment of disease other than exploratory laparotomy or biopsy
will be allowed

- No previous systemic chemotherapy will be allowed

- No prior pelvic radiation therapy is permitted other than transvaginal irradiation to
control bleeding will be allowed

- Women of childbearing potential who have a positive result on screening serum
pregnancy test

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility

Safety Issue:

No

Principal Investigator

Lillie Lin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 22808

NCT ID:

NCT01019278

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Stage IB Cervical Cancer
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage IVA Cervical Cancer
  • Uterine Cervical Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283