Short-course (hypofractionated) IMRT with weekly cisplatin for locally advanced cervical cancer

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

This trial tests whether a shorter course of targeted pelvic radiation (hypofractionated IMRT) plus weekly cisplatin works and is safe for people with locally advanced cervical cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 20 Years and up
• Sex: Female
• Sponsor: Samsung Medical Center (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Seoul, Gangnam-gu)
• Trial ID: NCT07439497 on ClinicalTrials.gov

What this trial studies

Patients with FIGO stage IIB–IVA cervical cancer receive hypofractionated intensity-modulated radiation therapy to the pelvis together with weekly cisplatin (40 mg/m²). Pelvic nodal regions are treated to about 40–50 Gy with possible sequential boosts to gross nodal disease or the parametrium and intracavitary brachytherapy when indicated. The primary endpoint is tumor volume reduction rate measured on pelvic MRI one month after treatment, and secondary endpoints include 3-year local recurrence rate, progression-free survival, and incidence of acute and late grade ≥3 toxicities. The protocol aims to shorten overall treatment time relative to conventional schedules while keeping tumor control and safety acceptable.

Who should consider this trial

Good fit: Ideal candidates are adults (≥20 years) with histologically confirmed cervical cancer (squamous, adeno, or adenosquamous), FIGO IIB–IVA, a measurable primary tumor on recent pelvic MRI, ECOG 0–1, adequate blood and renal function, and no prior pelvic radiotherapy or distant metastases.

Not a fit: Patients with distant metastasis, prior pelvic radiotherapy or prior definitive chemoradiotherapy, those who already had definitive surgery for the current lesion, or who have poor performance status are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, patients could complete curative chemoradiation in less time with similar tumor control and potentially fewer treatment delays or long-term toxicities.

How similar studies have performed: Hypofractionation as a definitive approach in cervical cancer is relatively novel with limited prospective data, though smaller retrospective series and related regimens have shown encouraging signals.

Eligibility 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:

* 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

Where this trial is running

Seoul, Gangnam-gu

• Samsung Medical Center — Seoul, Gangnam-gu, South Korea (RECRUITING)

Study contacts

• Study coordinator: won park

Conditions: Cervical Cancer, Concurrent Chemoradiotherapy