Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

This is a Phase II, single-center, single-arm, study of Stereotactic Body Radiotherapy boost
for stage IB-IVB cervical cancer.

The primary objective of the study is to test the hypothesis that stereotactic body radiation
therapy (SBRT) leads to an improvement in treatment-related symptoms of post traumatic stress
compared to brachytherapy (historical control) according to the Impact of Event
Scale-Revision (IES-R).

Study participants will be recruited within the UCSD Health System. For those patients under
the clinical management of the recruiting investigator, the investigator will review the
patient's medical records and determine if they would be a candidate for the study. The
investigator will approach the subject and offer participation in the trial. If the patient
chooses to participate, they will undergo pretreatment evaluations to determine if they are a
good candidate to participate further in the study. Depending on when the patient last had
these tests and procedures performed, some of them may not need to be repeated.

Upon confirmation of all eligibility criteria, the subject will be enrolled. Each enrolled
subject will receive radiation therapy consisting of 30 to 35 treatments. The patient will
first undergo Whole Pelvis Radiation Therapy 40 - 50.4 Gy in 1.8 - 2.0 Gy daily fractions
over 4.5 - 5.5 weeks, followed by Stereotactic Body Radiotherapy 5.5 - 8.0 Gy per fraction x
5 fractions using arc therapy. Concurrent chemotherapy may be given with radiation therapy
according to the discretion of the treating oncology team. No chemotherapy will be given
during the SBRT phase of treatment. During radiation therapy, the patient will have a weekly
physical exam, vital signs collected, evaluation for pain, and review any side effects.

Subjects will undergo a post treatment follow-up period after completion of their radiation
therapy. During this follow-up period, subjects will return for a medical and history review
with a complete physical examination, review of any side effects, evaluation for outcomes and
toxicity, and evaluations for stress, anxiety, and pain.

Inclusion Criteria:

- Biopsy-proven, invasive carcinoma of the cervix.

- Candidate for pelvic, pelvic-inguinal, or extended field radiotherapy with or without
concurrent chemotherapy. Patients undergoing preoperative or adjuvant chemotherapy are
excluded.

- History/physical examination within 60 days prior to registration to document cervical
tumor size and stage

- CT, MRI, or PET/CT imaging of the chest, abdomen, and pelvic regions within 60 days
prior to registration (for stage I patients, PA and lateral chest x-ray is sufficient
for chest imaging)

- Age ≥ 18

- Negative serum pregnancy test for women of child-bearing potential

- Women of childbearing potential must agree to practice effective birth control
throughout their participation in the treatment phase of the study.

- Patients must sign informed consent prior to study entry.

Exclusion Criteria:

- Prior radiotherapy to the pelvis or abdomen that would result in overlap of radiation
therapy fields.

- Prior hysterectomy.

- Women who are pregnant or lactating are ineligible due to teratogenic effects on
developing fetuses. Women who are of child-bearing potential need to practice
effective methods of contraception including oral contraceptives, intrauterine device,
diaphragm with spermicides, and/or abstinence.

- Patients undergoing preoperative or adjuvant chemotherapy

- History of pre-existing PTSD.

- History of major psychiatric disorder.