Comparing two radiation therapy methods for high-risk cervical cancer after surgery

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

This phase 3 multicenter randomized controlled trial evaluates the effectiveness of conventional fractionated IMRT versus hypofractionated IMRT in high-risk cervical cancer patients who have undergone radical hysterectomy. Participants will be randomly assigned to receive one of the two radiation therapy regimens in combination with concurrent chemotherapy. The study aims to assess local control rates, overall survival, disease-free survival, and the profiles of acute and late toxicities associated with each treatment approach. The trial will also consider factors such as lymph node metastasis status and tumor type during randomization.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients diagnosed histologically with cervical cancer
* Patients diagnosed histologically with Squamous cell carcinoma, Adenocarcinoma, or Adenosquamous carcinoma
* Patients who have undergone radical hysterectomy and pelvic lymphadenectomy
* Patients who meet the indication for radiotherapy in postoperative pathological examination (at least on of the following):

A. Pelvic lymph node metastasis B. Parametrial involvement C. Positive surgical margins

* Adult aged 20 to 75 years
* Patients with an ECOG 0-1 within 1 week prior to study participation
* Maintained bone marrow function: granulocyte ≥1.0 x 103/µl, platelets ≥30 x 103/µl, hemoglobin ≥9.5 g/dl
* Maintained renal and liver function (Creatinine \<2.0 mg/dL, Bilirubin \< 1.5 mg/dl)
* Patients who have voluntarily signed the consent form

Exclusion Criteria:

* Patients with distance metastasis (including ovarian and para-aortic lymph node metastasis)
* Patients who have previously received radiotherapy to the pelvic area
* Patients who have undergone radical hysterectomy more than 3 months prior
* Patients with untreated serious acute illnesses (e.g., stroke, cerebral infarction, myocardial infarction) other than cervical cancer
* Patients who received neoadjuvant chemotherapy before surgery
* Patients who will not receive concurrent chemotherapy during radiotherapy
* Patients with a history of another cancer diagnosis within the past 5 years, except for thyroid cancer, skin cancer, or carcinoma in suit

Where it's running

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

Study contacts

• Study coordinator: Won Park, M.D.,Ph.D
• 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.