Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

NCT03146039 | Withdrawn Phase 2 DMC FDA Device

• 1 other identifier: UCSD 161328
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Patients with Adverse Events Following SBRT as a Measure of Safety

  2 years

• Ranking Quality of Life of Patients

  2 years

• Ranking Quality of Life of Patients

  2 years

• Number of Intrafraction Cervical Motion

  2 years

Study Arms (1)

Radiation Therapy

OTHER

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

Interventions

Radiation Therapy RADIATION

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.

Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Moores UC San Diego Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Loren Mell, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 9, 2017
• Study Start: June 2, 2017
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

US (1)