Hypofractionated Radiochemotherapy

Launched by DENISE FABIAN · Mar 19, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat women with advanced cervical cancer, specifically those whose tumors are large or have spread (metastatic) but do not require immediate systemic therapy. The study explores a method called hypofractionated radiochemotherapy, which means giving fewer but larger doses of radiation along with a chemotherapy drug called cisplatin. Researchers want to find out how well this treatment works, how safe it is, and how long patients can go without their cancer worsening after treatment. Eligible participants are women aged 18 and older with specific types of advanced cervical cancer, and they must not have had prior pelvic radiation or another active cancer.

If you or a loved one participates, you can expect to receive the treatment on an outpatient basis, meaning you won't need to stay in the hospital. The trial includes a total of eight radiation sessions and two cycles of chemotherapy, all completed within a set timeframe. Participants will have regular check-ups and scans to monitor their response to treatment and any side effects. Importantly, the trial is not yet recruiting, so it may take some time before enrollment begins. If you have questions about eligibility or the treatment process, discussing them with your healthcare provider can help provide more personalized information.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Untreated, pathologically or cytologically-confirmed diagnosis of FIGO Stage IB3, II, or IIIA-IIIC1 bulky ( ≥ 6cm) or Stage IVB (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix with limited metastatic burden (not requiring urgent systemic therapy).
• • Adequate organ and marrow function
• • Gynecologic Oncology Group performance status of 0, 1, or 2
• • Patient agrees to use two forms of birth control if they are of child-bearing potential
• • Ability to understand and the willingness to sign a written informed consent document
• Exclusion Criteria:
• • Presence of another concurrent active invasive malignancy
• • Prior invasive malignancy diagnosed within the last three years, with the following two exceptions: \[a\] non-melanoma skin cancer and/or \[b\] prior in situ carcinoma of the cervix
• • Receipt of prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues, at the discretion of the treating physician
• • Currently receiving any other investigational agent(s) for the treatment of cancer
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cisplatin or other agents used in study
• • Presence of uncontrolled intercurrent illness as determined by the treating physician
• • pregnant or lactating
• • Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better