MedTrace Logo

Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB

NCT03146039 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-02-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Loren Mell, MD · University of California, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2019-05-15
Completion
2019-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03146039 on ClinicalTrials.gov