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

NCT07439497 | Recruiting Phase 2 DMC

• 1 other identifier: SMC 2025-06-146
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer

Keywords

Cervical Cancer; Concurrent Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

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

  1 month after completion of treatment

Secondary Outcomes (4)

• 3 years local recurrence

  3 years after treatment initiation

• 3 years progression-free survival (PFS)

  3 years after treatment initiation

• incidence of acute and late adverse events ≥ Grade 3

  During RT treatment to Post RT 3 years

• Prognostic factor analysis for local recurrence and progression-free survival

  3 years after treatment initiation

Study Arms (1)

Definitive hypofractionated intensity-modulated radiation theraphy with concurrent chemotherapy

EXPERIMENTAL

Radiation: Definitive hypofractionated intensity-modulated radiation theraphy; Drug: concurrent chemotherapy

Interventions

Definitive hypofractionated intensity-modulated radiation theraphy RADIATION

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.

Definitive hypofractionated intensity-modulated radiation theraphy with concurrent chemotherapy

concurrent chemotherapy DRUG

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.

Definitive hypofractionated intensity-modulated radiation theraphy with concurrent chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

won park

CONTACT

+82-10-9933-2616; wonro.park@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 27, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

KR (1)