Actively Recruiting

Phase 2
Age: 20Years +
FEMALE
NCT07439497

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

Led by Samsung Medical Center · Updated on 2026-02-27

34

Participants Needed

1

Research Sites

129 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 20Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 65 20 years
  • ECOG performance status 0-1
  • Adequate bone marrow function: WBC 65 3,000/bcL, ANC 65 1,000/bcL, platelets 65 100,000/bcL, hemoglobin 65 9 g/dL
  • Adequate renal function: Creatinine < 2.0 mg/dL
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, Gangnam-gu, South Korea, 06351

Actively Recruiting

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Research Team

W

won park

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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