Definitive hypofractionated intensity-modulated radiation theraphy with concurrent chemotherapy in cervical cancer: A prospective phase II trial (DEHIM_CCRT trial)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0010935

Enrollment

Registered

2025-08-22

Start date

2025-09-01

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, 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 r

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Tumor Volume Redution Rate (TVRR) at 1 month after completion of treatment based on MRI	—

Secondary

Measure	Time frame
3 years local recurrence;3 years progression-free survival (PFS);incidence of acute and late adverse events = Grade 3;Prognostic factor analysis for local recurrence and progression-free survival	—

Countries

Korea, Republic of

Contacts

Public Contactchewon Ko

Samsung Medical Center

chewonttu@gmail.com+82-2-2148-7151

Outcome results