Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB (NICER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03146039|
Recruitment Status : Not yet recruiting
First Posted : May 9, 2017
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Radiation: Radiation Therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Invasive Cervical Cancer Radiotherapy: Phase II Clinical Trial of Stereotactic Body Radiotherapy Boost for Stage IB-IVB Cervical Cancer|
|Estimated Study Start Date :||May 2017|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
The patient will receive 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.
Radiation: Radiation Therapy
Whole pelvis radiation therapy will be delivered according to institutional standard of care.
SBRT is delivered with 5 fractions of 5.5-8 Gy prescribed to the high-risk CTV, with dose constraints identical to those for high dose rate, volume-directed brachytherapy. The patient will undergo arc therapy with a minimum of two arcs. On-line kV CBCT will be used to verify the isocenter prior to each arc delivery. Patients will be resimulated for SBRT boost planning.
- Number of Treatment-Related Symptoms of Post Traumatic Stress [ Time Frame: 2 years ]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).
- Number of Patients with Adverse Events Following SBRT as a Measure of Safety [ Time Frame: 2 years ]To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity following SBRT.
- Ranking Quality of Life of Patients [ Time Frame: 2 years ]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).
- Ranking Quality of Life of Patients [ Time Frame: 2 years ]To measure health-related quality of life based on the cervical cancer module (CX24).
- Number of Intrafraction Cervical Motion [ Time Frame: 2 years ]To quantify intrafraction cervical motion using cone beam computed tomography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146039
|United States, California|
|Moores UC San Diego Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Loren Mell, MD||University of California, San Diego|