Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda
NCT ID: NCT07276360
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
278 participants
INTERVENTIONAL
2026-01-03
2029-01-02
Brief Summary
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Detailed Description
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I. 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:
I. 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).
V. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (HFRT)
Patients 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.
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).
Cisplatin
Undergoing Cisplatin
High-Dose Rate Brachytherapy
Undergoing HDR Brachytherapy
External Beam Radiotherapy Boost
Undergoing external beam radiotherapy boost
Computed Tomography
Undergoing CT scan
Biospecimen Collection
Undergoing blood sample collection
Questionnaire and Physical Exam
Ancillary Studies
Arm II (CFRT)
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.
Conventional Fractionated Radiotherapy
Undergoing CFRT
Cisplatin
Undergoing Cisplatin
High-Dose Rate Brachytherapy
Undergoing HDR Brachytherapy
External Beam Radiotherapy Boost
Undergoing external beam radiotherapy boost
Computed Tomography
Undergoing CT scan
Biospecimen Collection
Undergoing blood sample collection
Questionnaire and Physical Exam
Ancillary Studies
Interventions
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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).
Conventional Fractionated Radiotherapy
Undergoing CFRT
Cisplatin
Undergoing Cisplatin
High-Dose Rate Brachytherapy
Undergoing HDR Brachytherapy
External Beam Radiotherapy Boost
Undergoing external beam radiotherapy boost
Computed Tomography
Undergoing CT scan
Biospecimen Collection
Undergoing blood sample collection
Questionnaire and Physical Exam
Ancillary Studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Uganda Cancer Institute
OTHER
Varian Medical Systems
INDUSTRY
Fogarty International Center of the National Institute of Health
NIH
Responsible Party
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Principal Investigators
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Solomon Kibudde, MBChB, MMed.
Role: PRINCIPAL_INVESTIGATOR
Uganda Cancer Institute
Locations
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Uganda Cancer Institute
Kampala, Kampala, Uganda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS5348ES
Identifier Type: OTHER
Identifier Source: secondary_id
Mak-SOMREC-2023-775
Identifier Type: OTHER
Identifier Source: secondary_id
RG1125359
Identifier Type: OTHER
Identifier Source: secondary_id
U050
Identifier Type: -
Identifier Source: org_study_id
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