Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer

NCT07439497 · tracked via the Priya Life Science South Korea tracker

Sponsor

Samsung Medical Center

Phase

Phase 2

Started

2025-12-09

Last updated

2026-02-27

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Definitive hypofractionated intensity-modulated radiation theraphyconcurrent chemotherapy

Definitive hypofractionated intensity-modulated radiation theraphy: Patients receive weekly cisplatin at 40 mg/m² intravenously on days 1, 8, 15, 22, and 29, concurrently with external beam radiotherapy (EBRT). EBRT is delivered to the pelvic nodal regions at 1.8-2.0 Gy per fraction up to a total dose of 40-50 Gy. Sequential EBRT boost of 10-20 Gy to grossly positive nodal disease or 5-10 Gy to the parametrium may be applied if needed. The overall treatment course lasts approximately 7-8 weeks, and intracavitary brachytherapy (ICR) may be additionally performed when indicated.

concurrent chemotherapy: Patients receive weekly cisplatin at 40 mg/m² intravenously on days 1, 8, 15, 22, and 29, concurrently with external beam radiotherapy (EBRT). EBRT is delivered to the pelvic nodal regions at 1.8-2.0 Gy per fraction up to a total dose of 40-50 Gy. Sequential EBRT boost of 10-20 Gy to grossly positive nodal disease or 5-10 Gy to the parametrium may be applied if needed. The overall treatment course lasts approximately 7-8 weeks, and intracavitary brachytherapy (ICR) may be additionally performed when indicated.

Study summary

This study aims to evaluate the efficacy and safety of hypofractionated intensity-modulated radiation therapy (IMRT) combined with concurrent chemotherapy in patients with cervical cancer. Conventional treatment usually requires 7-8 weeks, which increases the risk of toxicities and treatment delays. This trial seeks to shorten the overall treatment time while maintaining non-inferior tumor response and survival outcomes compared to standard therapy. The primary endpoint is tumor volume reduction rate (TVRR) assessed by pelvic MRI at 1 month after treatment. Secondary endpoints include 3-year local recurrence rate, progression-free survival, and incidence of acute and late grade ≥3 toxicities. The results of this study are expected to contribute to establishing an optimal treatment strategy for cervical cancer.

Eligibility

Sex

FEMALE

Min age

20 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Histologically confirmed cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) * FIGO stage IIB-IVA (2018) * Measurable primary tumor on pelvic MRI within 30 days prior to treatment initiation * Age ≥ 20 years * ECOG performance status 0-1 * Adequate bone marrow function: WBC ≥ 3,000/µL, ANC ≥ 1,000/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9 g/dL * Adequate renal function: Creatinine \< 2.0 mg/dL * Ability to provide written informed consent Exclusion Criteria: * Patients with distant metastasis * Patients who have previously received pelvic radiotherapy * Patients who have previously received definitive chemotherapy or chemoradiotherapy for diagnosed cervical cancer * Patients who have undergone surgery for the current cervical cancer lesion * Patients who underwent local excisional procedures of the cervix such as conization or Loop Electrosurgical Excision Procedure (LEEP) prior to radiotherapy * Patients who are unable to undergo concurrent chemoradiotherapy due to poor general condition * Patients with other active malignancies (except carcinoma in situ of the cervix, basal cell carcinoma of the skin, or superficial bladder cancer) within 3 years prior to enrollment or who experienced recurrence within 3 years after treatment

Primary outcome measure(s)

Tumor Volume Redution Rate (TVRR) at 1 month after completion of treatment based on MRI — 1 month after completion of treatment

Trial sites (1)

Facility	City	Region	Status
Samsung Medical Center	Seoul	Gangnam-gu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07439497 on ClinicalTrials.gov ↗ ← All trials in South Korea