Cervical Cancers
Conditions
Keywords
high dose rate brachytherapy
Brief summary
This is a prospective non-randomized clinical trial to evaluate the feasibility of 3 fraction versus a standard 4 fraction high dose rate brachytherapy regimen in patients with locally advanced cervical cancer.
Interventions
RADIATION3-Fraction HDR Brachytherapy
8 Gy per fraction for 3 fractions (total 24 Gy) for patients with locally advanced cervical cancer, based on individualized planning.
RADIATION4-Fraction HDR Brachytherapy
7 Gy per fraction for 4 fractions (total 28 Gy) as the standard-of-care brachytherapy regimen.
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically documented malignancy of the cervix and planned to receive brachytherapy as part of definitive treatment. * ECOG performance status of 0-2 * Age ≥ 18 years old. * Ability to understand and the willingness to provide written informed consent.
Exclusion criteria
* Contraindication to receiving radiotherapy as determined by treating radiation oncologist. * Contraindication to receiving MRI. * Prior radiation to the pelvis \> 3 months ago * Age \< 18 years old. * Pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen | Up to 8 months | Proportion of patients that underwent a 3 fraction brachytherapy regimen. |
Countries
United States
Contacts
CONTACTAlyssa Yauger
CONTACTJillian Skerchak
PRINCIPAL_INVESTIGATORElizabeth Kidd, MD
Stanford University
Outcome results
None listed