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Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB (NICER)

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ClinicalTrials.gov Identifier: NCT03146039
Recruitment Status : Not yet recruiting
First Posted : May 9, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Loren Mell, MD, University of California, San Diego

Brief 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.

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

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Radiation Therapy
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.





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. Ranking Quality of Life of Patients [ Time Frame: 2 years ]
    To measure health-related quality of life based on the cervical cancer module (CX24).

  4. Number of Intrafraction Cervical Motion [ Time Frame: 2 years ]
    To quantify intrafraction cervical motion using cone beam computed tomography.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: CTO 858-822-5354 CancerCTO@ucsd.edu

Locations
United States, California
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Loren Mell, MD University of California, San Diego

Responsible Party: Loren Mell, MD, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03146039     History of Changes
Other Study ID Numbers: UCSD 161328
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female