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

February 24, 2026 updated by: Won Park, Samsung Medical Center

Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Phase II Trial (DEHIM_CCRT Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gangnam-gu
      • Seoul, Gangnam-gu, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Definitive hypofractionated intensity-modulated radiation theraphy with concurrent chemotherapy
Radiation: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor Volume Redution Rate (TVRR) at 1 month after completion of treatment based on MRI
Time Frame: 1 month after completion of treatment
1 month after completion of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
3 years local recurrence
Time Frame: 3 years after treatment initiation
3 years after treatment initiation
3 years progression-free survival (PFS)
Time Frame: 3 years after treatment initiation
3 years after treatment initiation
incidence of acute and late adverse events ≥ Grade 3
Time Frame: During RT treatment to Post RT 3 years
During RT treatment to Post RT 3 years
Prognostic factor analysis for local recurrence and progression-free survival
Time Frame: 3 years after treatment initiation
3 years after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC 2025-06-146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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