Comparing two radiation therapy methods for high-risk cervical cancer after surgery
Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Multicenter Randomized Phase III Trial (POHIM_P3 Trial)
This study is testing two different radiation therapy methods to see which one works better for women with high-risk cervical cancer after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul, Gangnam-gu) |
| Trial ID | NCT06509724 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 to 75 with histologically confirmed cervical cancer who have undergone radical hysterectomy and meet specific postoperative criteria for radiotherapy.
Not a fit: Patients with distant metastasis or those who have previously received radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer radiation therapy option for high-risk cervical cancer patients post-surgery.
How similar studies have performed: Previous studies have shown promising results with hypofractionated IMRT in early cervical cancer, suggesting potential success for this approach in high-risk patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul, Gangnam-gu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.