NCT07439497RecruitingPhase 2
Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer
Definitive Hypofractionated Intensity-modulated Radiation Theraphy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Phase II Trial (DEHIM_CCRT Trial)
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 29 Dec 2025
- Start date
- 9 Dec 2025
- Primary completion date
- 30 May 2026
- Lead sponsor
- Samsung Medical Center
- Diseases
- Cervical cancer
- NCT number
- NCT07439497
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 34
- From 9 Dec 2025 to the primary completion date, 30 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received pelvic radiotherapy
- Patients who have previously received definitive chemotherapy or chemoradiotherapy for diagnosed cervical cancer
- 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
Other illness
- Patients who have undergone surgery for the current cervical cancer lesion
Other
- Patients with distant metastasis
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.