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New treatment option for Cervical Cancer
Official title Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda
ClinicalTrials.gov ID: NCT07276360
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for cervical cancer.
Also referred to as CDDP, Abiplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial compares the effect of hypofractionated radiotherapy (HFRT) to conventional fractionated radiotherapy (CFRT) when given in combination with cisplatin and brachytherapy in patients with stage IB3, II, or III cervical cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Females aged 18 years or older
- Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment
- Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3, IIA, IIB, IIIA, IIIB, or IIIC
- Able to provide written informed consent in English, Luganda, Runyankole, or Lango
- Willing to attend post-treatment follow-up for up to 12 months
You likely can't join if
- Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the...
- Clinical and/or radiological evidence of distant metastases
- Prior pelvic or abdominal radiotherapy
- Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment
- History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment
- Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may...
See the full eligibility criteria
- Females aged 18 years or older
- Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment
- Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3, IIA, IIB, IIIA, IIIB, or IIIC
- Able to provide written informed consent in English, Luganda, Runyankole, or Lango
- Willing to attend post-treatment follow-up for up to 12 months
- Fit for concurrent chemotherapy with cisplatin
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2
- Absolute neutrophil count ≥ 1,500 cells/mm\^3 (1.5 x 10\^9/L)
- Platelets ≥ 100,000 cells/mm\^3 (100 x 10\^9/L)
- Hemoglobin ≥ 9.0 g/dL
- Leukocyte count ≥ 4,000 cells/mm\^3 (4.0 x 10\^9/L)
- Creatinine clearance \> 60 mL/mins, calculated using the Cockcroft-gault equation for women
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times the upper limit of normal (ULN)
- Total bilirubin \< 2 x ULN unless attributed to the use of antiretroviral therapy (ART)
- HIV-positive participants must be on a stable ART regimen for at least 6 weeks prior to enrollment
- Prior hysterectomy. Women with previous total or subtotal hysterectomy have no cervix, and hence the anatomical changes have an impact on the radiotherapy field, and dose prescriptions because they tend to have a higher...
- Clinical and/or radiological evidence of distant metastases
- Prior pelvic or abdominal radiotherapy
- Presence of bilateral hip prosthesis that could interfere with radiotherapy treatment
- History of inflammatory bowel disease or any other condition that could complicate radiotherapy treatment
- Participants who are pregnant at the time of enrollment. Pregnant women have a potential risk of radiation exposure to developing fetus, which may result in fetal malformations, growth retardation, or even fatal death...
- Concurrent untreated invasive malignancy
- Uncontrolled concurrent medical/psychiatric diagnosis that would limit compliance with study requirements
- Uncontrolled HIV infection, especially HIV viral load \> 2,000 copies/mL
- Participants with CD4 counts \< 200 cells/mm\^3
The study team makes the final eligibility decision.
Where it's taking place
- Kampala, Kampala, Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kampala, Kampala, Uganda. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.