Cervical Cancer Clinical Trial
— NICEROfficial title:
Non-Invasive Cervical Cancer Radiotherapy: Phase II Clinical Trial of Stereotactic Body Radiotherapy Boost for Stage IB-IVB Cervical Cancer
Verified date | January 2020 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 15, 2019 |
Est. primary completion date | May 15, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Moores UC San Diego Cancer Center | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Treatment-Related Symptoms of Post Traumatic Stress | To quantify treatment-related symptoms of post traumatic stress to determine if 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). | 2 years | |
Secondary | Number of Patients with Adverse Events Following SBRT as a Measure of Safety | To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity following SBRT. | 2 years | |
Secondary | Ranking Quality of Life of Patients | To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30). | 2 years | |
Secondary | Ranking Quality of Life of Patients | To measure health-related quality of life based on the cervical cancer module (CX24). | 2 years | |
Secondary | Number of Intrafraction Cervical Motion | To quantify intrafraction cervical motion using cone beam computed tomography. | 2 years |
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