A Phase II Study for Image Guided Hypofractionated Radiation Boost Therapy for Definitive Treatment of Locally Advanced Cervical Cancer
- Clements University Hospital
Patients enrolled in this study must have received or planned to receive 45Gy of prior external beam radiation therapy. Following completion, patients will receive 28 Gy in 4 fractions using image Guided Hypofractionated radiation therapy techniques. image Guided Hypofractionated Radiation Treatment boost therapy will be compared to standard of care which consists of standard chemoradiation followed by intracavitary high dose rate brachytherapy.
The study is a prospective single-arm phase ii trial of stereotactic body radiation therapy boost therapy in the definitive treatment of locally advanced cervical cancer. The study will determine whether image Guided Hypofractionated Radiation Treatment boost therapy is efficacious in women with locally advanced cervical cancer without increased risk of acute Gi or Gu toxicity. Study endpoints include local control rate, and , toxicity assessed by CTCaev4
3.1.1 Biopsy proven Locally Advanced stage Cervical Cancer (LACC, FIGO IB2 x IVB)
3.1.2 Zubrod performance status 0-3
3.1.3 Women of child-bearing potential (See note) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
3.1.4 Patients should have any of the below to be eligible
* Are not candidates for intracavitary brachytherapy due to poor geometry or poor response to external beam RT
* Patients with co-morbid medical conditions, bleeding disorders , poor anesthetic risk precluding brachytherapy
* Patients who refuse brachytherapy or prefer external beam hypofractionated approach
* Patients requiring interstitial brachytherapy
Note: Patients may be discovered during standard therapy and enrolled prior to boost.
Note: A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).