NCT06509724 Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
| NCT ID | NCT06509724 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Samsung Medical Center |
| Condition | Uterine Cervical Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 248 participants in total. It began in 2024-07-19 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Radical hysterectomy and radiation therapy are standard treatments for cervical cancer. However, there are no reported studies on the frequency of side effects and treatment outcomes when hypofractionated radiation therapy and intensity modulated radiation therapy(IMRT) are used during radiation therapy. Hypofractionated radiation therapy increases the daily dose and reduces the number of treatment sessions, which may increase the risk of side effects, but its safety has been confirmed in some cases of early cervical cancer and endometrial cancer. Additionally, applying IMRT, a technique designed to protect normal tissue, during concurrent chemoradiotherapy has shown positive results in reducing the incidence of acute side effects. Investigators previously demonstrated that combining hypofractionated IMRT with chemotherapy for high-risk postoperative cervical cancer patients resulted in high survival rates and low toxicity in a phase 2 exploratory study. Base on this result, this study aimed to compare the efficacy and safety of conventional fractionated radiation therapy and hypofractionated radiation therapy.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06509724 clinical trial?
This trial is open to female participants only, aged 20 Years or older, up to 75 Years, studying Uterine Cervical Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06509724 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 248 participants.
Is NCT06509724 currently recruiting?
Yes, NCT06509724 is actively recruiting participants. Contact the research team at wonro.park@samsung.com for enrollment information.
Where is the NCT06509724 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06509724 clinical trial?
NCT06509724 is sponsored by Samsung Medical Center. The trial plans to enroll 248 participants.