Study to Test Shorter Duration Chemoradiation Therapy Versus Standard Duration Chemoradiation Therapy for Cervical Cancer
Cervical Adenocarcinoma · Cervical Adenosquamous Carcinoma · Cervical Squamous Cell Carcinoma · Stage IB2 Cervical Cancer FIGO 2018 · Stage IB3 Cervical Cancer FIGO 2018 · Stage II Cervical Cancer FIGO 2018 · Stage IIIC1 Cervical Cancer FIGO 2018
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 3
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 550 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This phase III trial compares the effect of a shorter duration (hypofractionated) of intensity-modulated radiation therapy (IMRT) with brachytherapy and cisplatin to standard duration IMRT with brachytherapy and cisplatin in treating patients with newly diagnosed stage IB2-IIIC1 cervical cancer. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. A radiation boost is extra radiation to the area where the tumor is located which increases the amount of radiation given to the tumor bed. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving hypofractionated chemoradiation therapy may be as safe, tolerable and/or effective as the standard, longer course of chemoradiation therapy in treating patients newly diagnosed with stage IB2-IIIC1 cervical cancer.
Read the full description
PRIMARY OBJECTIVE:
I. To determine if hypofractionated IMRT with concurrent cisplatin and brachytherapy boost is non-inferior to conventionally fractionated treatment with respect to progression-free survival (PFS).
SECONDARY OBJECTIVES:
I. To estimate the rates of timely treatment completion. II. To determine the nature and degree of toxicity of hypofractionated IMRT with concurrent cisplatin and brachytherapy as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.
III. To evaluate late toxicity, progression-free survival, and overall survival (OS) at 3 years.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo IMRT with a simultaneous integrated boost once daily (QD) on Monday-Friday weekly for up to 5 weeks (25 treatment fractions) followed by brachytherapy for up to 3-5 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients receive cisplatin intravenously (IV) once weekly (QW) for up to 5 cycles while undergoing IMRT in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and positron emission tomography (PET)/computed tomography (CT), CT, or magnetic resonance imaging (MRI) throughout the study.
ARM 2: Patients undergo hypofractionated IMRT QD on 5 days per week for up to 3-4 weeks (15 treatment fractions) then a nodal boost (if indicated) for up to 4 treatment fractions followed by brachytherapy for up to 3-5 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients receive cisplatin IV QW for up to 5 cycles while undergoing IMRT in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and PET/CT, CT, or MRI throughout the study.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years then every 6 months for up to 3 years.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Patients must have histologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
- Patients must have a diagnosis of Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB2 (T1B2, N0), stage IB3 (T1B3N0), II (T2A-B, N0), IIIC1 (T1B2-3, N1), or IIIC1 (T2A-B, N1) squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix not amenable to curative surgical resection alone
- Negative for para-aortic disease AND treating physician does not plan to treat para-aortic nodes
- Radiologic definition of lymph node staging:
N1:
- One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
- One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standarized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose F-18 (FDG)-PET
- No prior definitive surgical, radiation, or systemic therapy for cervical cancer. Induction chemotherapy with weekly carboplatin (area under curve \[AUC\]2) and paclitaxel (80 mg/m\^2) for up to 6 weeks is allowed prior to study entry. This is the only permissible induction chemotherapy regimen prior to study entry
- No prior or concurrent immunotherapy
- No prior pelvic radiation therapy
- Age ≥/= 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Not pregnant and not nursing
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8 g/dl is acceptable)
- Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
- Patients with 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 II B or better
- No active infection requiring parenteral antibiotics
- No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
- No history of allergic reaction to cisplatin or compounds of similar chemical or biologic composition
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Arm 1 (standard IMRT, brachytherapy, cisplatin)
Patients undergo IMRT with a simultaneous integrated boost QD on Monday-Friday weekly for up to 5 weeks (25 treatment fractions) followed by brachytherapy for up to 3-5 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients receive cisplatin IV QW for up to 5 cycles while undergoing IMRT in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and PET/CT, CT, or MRI throughout the study.
Procedure: Biospecimen Collection · Radiation: Brachytherapy · Drug: Cisplatin · Procedure: Computed Tomography · Radiation: Intensity-Modulated Radiation Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Radiation: Radiation Boost
Arm 2 (hypofractionated IMRT, brachytherapy, cisplatin)
Patients undergo hypofractionated IMRT QD on 5 days per week for up to 3-4 weeks (15 treatment fractions) then a nodal boost (if indicated) for up to 4 treatment fractions followed by brachytherapy for up to 3-5 treatment fractions in the absence of disease progression or unacceptable toxicity. Patients receive cisplatin IV QW for up to 5 cycles while undergoing IMRT in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and PET/CT, CT, or MRI throughout the study.
Procedure: Biospecimen Collection · Radiation: Brachytherapy · Drug: Cisplatin · Procedure: Computed Tomography · Radiation: Hypofractionated External Beam Radiation Therapy · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Radiation: Radiation Boost
Biospecimen Collection PROCEDURE
Undergo blood sample collection
Brachytherapy RADIATION
Undergo brachytherapy
Cisplatin DRUG
Given IV
Computed Tomography PROCEDURE
Undergo CT or PET/CT
Hypofractionated External Beam Radiation Therapy RADIATION
Undergo hypofractionated IMRT
Intensity-Modulated Radiation Therapy RADIATION
Undergo IMRT
Magnetic Resonance Imaging PROCEDURE
Undergo MRI
Positron Emission Tomography PROCEDURE
Undergo PET/CT
Radiation Boost RADIATION
Undergo integrated boost
Radiation Boost RADIATION
Undergo a nodal boost
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Progression-free survival (PFS)
Time frame: From randomization to first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 3 years
Tests will be based on stratified log-rank tests to assess the randomized treatment effect among all randomized patients. Analyses will be supported by the intent-to-treat population, with patients analyzed according to their randomized treatment assignment. The log-rank tests will be stratified by the factor recorded at randomization. The treatment hazard ratio estimates and their 95% confidence intervals for the interim and primary analyses will be estimated using Cox proportional hazards models specified with a main effect for the randomized treatment assignment and stratified by the factor recorded at randomization.
Secondary measures
Rates of timely treatment completion
Time frame: From initiation of the assigned protocol therapy to treatment completion, assessed up to 46 days (for control arm) and up to 56 days (for experimental arm)
Will be defined as completing treatment within the protocol specified timeframes. Will be estimated for each treatment arm using binomial method, with corresponding confidence intervals, and the difference between treatment arms will be evaluated using 2-sided Fisher's exact test.
Incidence of acute adverse events (AEs)
Time frame: Up to 30 days after last dose of study treatment
The nature, frequency, and degree will be tabulated at the system organ class and AE-specific term levels using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Each patient will be represented by the maximum grade observed for each term. Tabulations will present the number and percentage of patients by maximum grade, within the treatment group received, regardless of the randomized treatment assignment. Will be dichotomized as severe (grade 3 or higher) or non-severe (grade 2 or lower). The proportion of patients experiencing severe toxicity will be estimated for each arm using the binomial method. The difference in proportions (experimental minus control) and its two-sided 90% confidence interval will be calculated. A 2-sided Fisher's exact test will be used to evaluate whether the distribution of severe toxicity differs between the 2 arms at 10% significance level.
Incidence of late AEs
Time frame: During follow-up beyond 30 days after stopping protocol treatment, assessed up to 3 years
The nature, frequency, and degree will be tabulated at the system organ class and AE-specific term levels using CTCAE v 5.0. Each patient will be represented by the maximum grade observed for each term. Tabulations will present the number and percentage of patients by maximum grade, within the treatment group received, regardless of the randomized treatment assignment. Will be dichotomized as severe (grade 3 or higher) or non-severe (grade 2 or lower). The proportion of patients experiencing severe toxicity will be estimated for each arm using the binomial method. The difference in proportions (experimental minus control) and its two-sided 90% confidence interval will be calculated. A 2-sided Fisher's exact test will be used to evaluate whether the distribution of severe toxicity differs between the 2 arms at 10% significance level.
PFS
Time frame: At 3 years
Will be estimated for each arm using Kaplan-Meier method. The distributions by treatment arm will be illustrated with Kaplan-Meier curves.
Overall survival
Time frame: At 3 years
Will be estimated for each arm using Kaplan-Meier method. The distributions by treatment arm will be illustrated with Kaplan-Meier curves. The treatment effect (Arm 2 versus Arm 1) will be evaluated using a 2-sided log-rank test, stratified by the factor specified at randomization. The hazard ratio and its 95% confidence intervals will be estimated using a Cox proportional hazards model, including main effects for the randomized treatment assignment (Arm 2 vs Arm 1) and stratified by the factor specified at randomization.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- NRG Oncology
- Study start
- May 19, 2027 Estimated
- Primary completion
- Jan 31, 2034 Estimated
- Study completion
- Jan 31, 2035 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Phase III Non-Inferiority Trial of Hypofractionated Chemoradiation Therapy Versus Standard Chemoradiation for Cervical Cancer
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026