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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Samsung Medical Center
  Seoul, Gangnam-gu, South Korea Recruiting

Study contacts

• Study coordinator: won park
• Email: wonro.park@samsung.com
• Phone: +82-10-9933-2616

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.