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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda

Phase II Randomized Non-Inferiority Trial of Hypofractionated Radiotherapy for Locally Advanced Cervical Cancer in Uganda

Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda (NCT07276360) is a Phase 2 interventional studying Cervical Cancer and Cervix Cancer, sponsored by Uganda Cancer Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. CFRT delivers the total dose of radiation over the amount of time according to standard practice. HFRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. HFRT shortens treatment duration and may reduce costs and may improve the completion rates. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HFRT may be safe, tolerable, and/or as effective as CFRT when given in combination with cisplatin and brachytherapy in treating patients with stage IB3, II or III cervical cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Cervical Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 278 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Cervical Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Females aged 18 years or older - diagnosed by tissue sample (biopsy-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 willing to sign a consent form 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) - platelet count at least 100,000 cells/mm\^3 (100 x 10\^9/L) - blood count (hemoglobin) at least 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 Who Should NOT Join This Trial: - 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 risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion 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 Exclusion Criteria: * 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 risk for bowel toxicity from pelvic radiotherapy. Therefore, these women will be excluded due to the likely impact on the results of our study intervention * 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. Secondly, their physiological changes alter the pharmacokinetics and pharmacodynamics of concurrent chemotherapy. Therefore, to protect the health of the mother and the unborn child, pregnant women will be excluded from the study. Patients who are found to be pregnant after enrollment will have the study procedures terminated * 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

Treatments Being Tested

RADIATION

Hypofractionated Radiation Therapy

Undergoing HFRT - The prescription dose will be 40 Gy in 16 fractions (2.5 Gy/fraction) to the entire pelvis, with concurrent integrated nodal boost at 3.0 Gy per fraction (48 Gy) to involved (positive) pelvic nodes, delivered once a day, Monday through Friday, 5 fractions per week, using volumetric modulated arc therapy (VMAT).

RADIATION

Conventional Fractionated Radiotherapy

Undergoing CFRT

DRUG

Cisplatin

Undergoing Cisplatin

RADIATION

High-Dose Rate Brachytherapy

Undergoing HDR Brachytherapy

RADIATION

External Beam Radiotherapy Boost

Undergoing external beam radiotherapy boost

PROCEDURE

Computed Tomography

Undergoing CT scan

PROCEDURE

Biospecimen Collection

Undergoing blood sample collection

OTHER

Questionnaire and Physical Exam

Ancillary Studies

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Uganda Cancer Institute
Kampala, Kampala, Uganda

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07276360), the sponsor (Uganda Cancer Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07276360 clinical trial studying?

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. CFRT delivers the total dose of radiation over the amount of time according to standard practice. HFRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. HFRT sh… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07276360?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07276360?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07276360. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07276360. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.