Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

Cervical Cancer Clinical Trial

— NICER  

Official title:

Non-Invasive Cervical Cancer Radiotherapy: Phase II Clinical Trial of Stereotactic Body Radiotherapy Boost for Stage IB-IVB Cervical Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03146039
• Other study ID #: UCSD 161328
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: January 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Cancer Stage
• Cervical Cancer Stage I
• Cervical Cancer Stage IB
• Cervical Cancer Stage IB1
• Cervical Cancer Stage IB2
• Cervical Cancer Stage II
• Cervical Cancer Stage IIa
• Cervical Cancer Stage IIIA
• Cervical Cancer Stage IIIB
• Cervical Cancer Stage Iv
• Cervical Cancer Stage IVA
• Cervical Cancer Stage IVB
• Cervical Cancer, Stage IIB
• Cervical Cancer, Stage III
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Moores UC San Diego Cancer Center	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

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