Study on Hypofractionated Radiochemotherapy for Women with Advanced Cervical Cancer
Sponsor: Denise Fabian
ClinicalTrials ID:NCT06331468
This clinical trial is exploring a new approach to treating women with advanced cervical cancer using fewer but larger doses of radiation combined with chemotherapy. The study aims to determine the effectiveness and safety of this treatment method.
Patient Parameters
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Program Overview
The purpose of this study is to test a new treatment method for women with advanced cervical cancer. This method uses fewer but larger doses of radiation, along with chemotherapy, to see if it can effectively control the cancer. The study will look at how well the cancer responds to treatment at 1 month and 3 months after treatment, how safe and tolerable the treatment is, and how long patients live without the cancer getting worse. It will also measure the number of cancer cells in the blood before and after treatment. Patients will undergo various tests to confirm eligibility before starting the treatment, which will be given on an outpatient basis. The study will compare this new method to the standard treatment, which uses more frequent but smaller doses of radiation and more cycles of chemotherapy.
Description
This study is testing a new way to treat advanced cervical cancer by using fewer but larger doses of radiation combined with chemotherapy. The treatment involves a shorter course of external beam radiation therapy (EBRT), with only 8 treatments instead of the usual 25. The chemotherapy involves 2 cycles of cisplatin instead of the usual 5-6 cycles. The treatment uses advanced techniques to focus the radiation on the cancer cells, and it must be completed within about 30 days. Patients will receive radiation therapy Monday through Thursday, and then brachytherapy, a type of internal radiation, twice a week. After the treatment, doctors will check for any side effects and see how well the cancer has responded. Patients will be followed for up to 2 years to monitor their health and the cancer's progression.
Eligibility Criteria
Inclusion Criteria
- Have not received treatment for cervical cancer and have a confirmed diagnosis of advanced cervical cancer (specific stages and types).
- Have good organ and bone marrow function.
- Have a performance status score of 0, 1, or 2, meaning they are fully active or have some limitations but can still care for themselves.
- Agree to use two forms of birth control if they can become pregnant.
- Understand the study and agree to sign informed consent.
Exclusion Criteria
- Have another active invasive cancer.
- Have had another invasive cancer diagnosed in the last three years, except for certain skin cancers or early-stage cervical cancer.
- Have received prior pelvic radiation that would exceed safe levels.
- Are currently receiving other experimental cancer treatments.
- Have a history of severe allergic reactions to similar drugs used in the study.
- Have uncontrolled illnesses as determined by the doctor.
- Are pregnant or breastfeeding.
- Have a history or current symptoms of heart disease and must meet certain heart health criteria to participate.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Markey Cancer Center | 40506 | Lexington | Kentucky |
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