Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

Withdrawn before enrolling · Phase 2

Conditions studied: Cervical Cancer, Cervical Cancer Stage, Cervical Cancer Stage IB2, Cervical Cancer Stage IB1, Cervical Cancer Stage I, Cervical Cancer Stage IB, Cervical Cancer Stage II, Cervical Cancer Stage IIa, Cervical Cancer, Stage IIB, Cervical Cancer, Stage III, Cervical Cancer Stage IIIB, Cervical Cancer Stage IIIA, Cervical Cancer Stage Iv, Cervical Cancer Stage IVA, Cervical Cancer Stage IVB

In brief

The purpose of this study is to find out whether patients with cervical cancer treated with about a new radiation technique called "stereotactic body radiotherapy (SBRT) have less stress and anxiety compared to standard brachytherapy radiation. With standard brachytherapy radiation, metal hardware is placed through the vagina and into the uterus, which can cause pain and discomfort. SBRT is a new radiation technique that is non-invasive and does not require the insertion of any metal hardware.

Key facts

Study ID

NCT03146039

Run by

University of California, San Diego

People needed

0

Starts

2017-06-02

Expected to finish

2019-05-15

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Moores UC San Diego Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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