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Cervical CancerPhase 2HypoRTCx-UGNCT07276360

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

A Phase 2 study testing Hypofractionated Radiation Therapy, Conventional Fractionated Radiotherapy and Cisplatin in people with Cervical Cancer and Cervix Cancer, run by Uganda Cancer Institute at 1 site in Uganda.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Hypofractionated Radiation Therapy, Conventional Fractionated Radiotherapy and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
278 participants
Where
1 siteUganda
Study dates
11 Mar 2026to 2 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Solomon Kibudde, MBChB, MMed. contact

+256773004608

solomon.kibudde@uci.or.ug

Uganda1 site, 1 recruiting

  • Uganda Cancer Institute

    Kampala, Kampala, 256

    Solomon Kibudde, MBChB, MMed, 0773004608, solomon.kibudde@uci.or.ug

    Recruiting

Other trials in Uganda

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety, and efficacy of hypofractionated radiotherapy (40 Gy in 16 fractions) compared to conventional fractionated radiotherapy (45 Gy in 25 fractions) in women with locally advanced cervical cancer in Uganda.

SPECIFIC OBJECTIVES:

  1. To compare the incidence of grade 3+ gastrointestinal and genitourinary toxicity at 1- and 2-years post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) and conventional fractionated radiotherapy (45 Gy in 25 fractions) in women with cervical cancer in Uganda.

II. To evaluate and compare local control and cervical cancer-specific survival rates at 1 and 2 year after hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional radiotherapy (45 Gy in 25 fractions).

III. To determine the association between stage-adjusted mean squamous cell carcinoma antigen (SCC-Ag) at 1-month post-treatment with the progression-free survival at 1- and 2- years post-treatment with hypofractionated radiotherapy (40 Gy in 16 fractions) or conventionally fractionated radiotherapy (45 Gy in 25 fractions).

IV. To compare the costs of healthcare to patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).

  1. To evaluate patient-reported outcomes and quality of life in patients with cervical cancer treated with hypofractionated radiotherapy (40 Gy in 16 fractions) versus conventional fractionated radiotherapy (45 Gy in 25 fractions).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (INTERVENTION): Patients undergo HFRT once daily (QD), Monday-Friday, for 5 fractions weekly for 16 fractions in the absence of disease progression or unacceptable toxicity. Starting on day 1 of radiation therapy, patients receive cisplatin infusion over 1 hour once weekly (QW) during radiation therapy. Starting by week 4, patients may also undergo high dose rate (HDR) brachytherapy twice weekly for a total of 4 doses. Patients ineligible for brachytherapy undergo a sequential external beam boost. Additionally, patients undergo computed tomography (CT) and blood sample collection throughout the study.

ARM II (CONTROL): Patients undergo CFRT QD, Monday-Friday, for 5 fractions weekly for up to 25 fractions in the absence of disease progression or unacceptable toxicity. Starting on day 1 of radiation therapy, patients receive cisplatin infusion over 1 hour QW during radiation therapy. Starting by week 4, patients may also undergo HDR brachytherapy twice weekly for a total of 4 doses. Patients ineligible for brachytherapy undergo a sequential external beam boost. Additionally, patients undergo CT and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30, 90, 180, 360, 540, and 720 days.

Being tested
Hypofractionated Radiation Therapy, Conventional Fractionated Radiotherapy, Cisplatin, High-Dose Rate Brachytherapy, External Beam Radiotherapy Boost
Keywords
Cervical cancer, Radiotherapy, Hypofractionation, Uganda
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated Radiation TherapyRadiation

    Also called Hypofractionated, hypofractionated radiotherapy, Hypofractionation, Moderately Hypofractionated Radiotherapy

    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).

  • Conventional Fractionated RadiotherapyRadiation

    Also called Normofractionated Radiotherapy, Conventionally Fractionated Radiotherapy

    Undergoing CFRT

  • CisplatinDrug

    Also called CDDP, Abiplatin, Platinum

    Undergoing Cisplatin

  • High-Dose Rate BrachytherapyRadiation

    Also called Brachytherapy, HDR, HDR Brachytherapy, High dose brachytherapy

    Undergoing HDR Brachytherapy

  • External Beam Radiotherapy BoostRadiation

    Also called Boost, EBRT Boost, Boost Radiotherapy, Radiotherapy Boost

    Undergoing external beam radiotherapy boost

  • Computed TomographyProcedure or surgery

    Also called CAT scan, CAT, Planning CT scan, CT scan

    Undergoing CT scan

  • Biospecimen CollectionProcedure or surgery

    Also called Blood sample, Biological sample collection, Biospecimen collected, Specimen collection

    Undergoing blood sample collection

  • Questionnaire and Physical ExamOther

    Also called CRF, Questionnaire, Assessment, Physical Exam

    Ancillary Studies

Study groups in NCT07276360
Study groupRoleWhat they receive
Arm I (HFRT)ExperimentalPatients undergo HFRT QD, Monday-Friday, for 5 fractions weekly for 16 fractions in the absence of disease progression or unacceptable toxicity. Starting on day 1 of radiation therapy, patients receive cisplatin infusion over 1 hour QW during radiation therapy. Starting by week 4, patients may also undergo HDR brachytherapy twice weekly for a total of 4 doses. Patients ineligible for brachytherapy undergo a sequential external beam boost. Additionally, patients undergo CT and blood sample collection throughout the study.
Receives: Radiation: Hypofractionated Radiation Therapy; Drug: Cisplatin; Radiation: High-Dose Rate Brachytherapy; Radiation: External Beam Radiotherapy Boost; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Questionnaire and Physical Exam
Arm II (CFRT)Active comparatorPatients undergo CFRT QD, Monday-Friday, for 5 fractions weekly for up to 25 fractions in the absence of disease progression or unacceptable toxicity. Starting on day 1 of radiation therapy, patients receive cisplatin infusion over 1 hour QW during radiation therapy. Starting by week 4, patients may also undergo HDR brachytherapy twice weekly for a total of 4 doses. Patients ineligible for brachytherapy undergo a sequential external beam boost. Additionally, patients undergo CT and blood sample collection throughout the study.
Receives: Radiation: Conventional Fractionated Radiotherapy; Drug: Cisplatin; Radiation: High-Dose Rate Brachytherapy; Radiation: External Beam Radiotherapy Boost; Procedure: Computed Tomography; Procedure: Biospecimen Collection; Other: Questionnaire and Physical Exam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    It will be categorized into 5 grades. The Conchran-Mantel-Haenszel test will be used to compare differences in the grades of AEs between patients who will receive hypofractionated radiotherapy versus conventional fractionated radiotherapy by stratifying for HIV status. A p-value of < 5% will be regarded as significant.

    Measured: Up to 90 days post-treatment

  2. Incidence of grade 3 or greater radiotherapy-related gastrointestinal or genitourinary AEs

    Will compare the proportion of patients between the hypofractionated radiotherapy and conventional fractionated radiotherapy using a risk difference approach, and the 95% confidence interval (CI) for the difference in proportion will be estimated using the Farrington-Manning test. Non-inferiority will be determined when the upper bound of a two-sided 95% CI is less than 10%.

    Measured: At 1 and 2 years post-treatment

  3. Local control (complete remission, stable disease, and partial response) rate

    Will be compared using means, medians, standard deviations, and ranges for continuous variables and frequencies and percentages for categorical variables. Differences in local control for each treatment group and the 95% CI will be calculated using the Chi-square test or Fisher's exact test. Data on tumor sizes that are normally distributed will be presented as means and standard deviations with 95% CI. The log-rank test will be used to compare the local control rates. The mean difference between groups will be calculated using an independent T-test for normally distributed data. Will compare the proportion between arms using a risk difference approach and the 95% CI, the difference in proportion will be estimated using the Farrington-Manning test. Non-inferiority will be determined when the upper bound of a two-sided 95% Confidence interval is less than 10%.

    Measured: At 1 and 2 years post-treatment

Secondary outcomes (2)

  1. Cervical cancer-specific survival

    Will be estimated for both groups using the Kaplan-Meier method. Non-inferiority will be declared when the upper bound of the two-sided 95% CI hazard ratio is less than 1.1. Multivariable Regression analysis will be used to estimate the association between the treatment arm and local control while adjusting for potential confounders such as age, stage, and hemoglobin level.

    Measured: At 1 and 2 years post-treatment

  2. Progression-free survival (PFS)

    Will be computed using the Kaplan-Meier survival curves, describing the median PFS and its 95% CI.

    Measured: From randomization to the date of first recurrence or progression of disease or death, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2025
  2. Study start11 Mar 2026
  3. Primary completion2 Jan 2028 (estimated)
  4. Study completion2 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an open-label phase II randomized non-inferiority trial with a parallel group design. One hundred and twenty participants will be randomized 1:1 into two arms - conventional fractionated radiotherapy or hypofractionated radiotherapy.
Masking
None (open label)
Enrolment
278 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07276360
Sponsor's protocol ID
U050
Other IDs
D43TW009759, HS5348ES, Mak-SOMREC-2023-775, RG1125359
Acronym
HypoRTCx-UG
Status last verified
Mar 2026
First submitted
30 Nov 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hypofractionated Radiation Therapy, Conventional Fractionated Radiotherapy and Cisplatin in people with Cervical Cancer and Cervix Cancer, run by Uganda Cancer Institute at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Solomon Kibudde, MBChB, MMed. (+256773004608, solomon.kibudde@uci.or.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: Up to 90 days post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07276360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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