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NCT Number: NCT07439497

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

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location status: Recruiting

Location contact

Samsung Medical Center

CONTACT

[email protected]

+82-2-3410-0200

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 1 month after completion of treatment

Secondary outcomes

  1. 3 years local recurrence

    Time frame: 3 years after treatment initiation

  2. 3 years progression-free survival (PFS)

    Time frame: 3 years after treatment initiation

  3. incidence of acute and late adverse events ≥ Grade 3

    Time frame: During RT treatment to Post RT 3 years

  4. Prognostic factor analysis for local recurrence and progression-free survival

    Time frame: 3 years after treatment initiation

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: DEHIM_CCRT

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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