NCT06509724RecruitingPhase 3
Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Multicenter Randomized Phase III Trial (POHIM_P3 Trial)
Source: ClinicalTrials.gov · Last updated 26 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 248 (estimated)
- First submitted
- 9 Jul 2024
- Start date
- 19 Jul 2024
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Samsung Medical Center
- Diseases
- Cervical cancer
- NCT number
- NCT06509724
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 248
- From 19 Jul 2024 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously received radiotherapy to the pelvic area
- Patients who have undergone radical hysterectomy more than 3 months prior
- Patients who received neoadjuvant chemotherapy before surgery
- Patients who will not receive concurrent chemotherapy during radiotherapy
Other illness
- Patients with untreated serious acute illnesses (e.g., stroke, cerebral infarction, myocardial infarction) other than cervical cancer
- Patients with a history of another cancer diagnosis within the past 5 years, except for thyroid cancer, skin cancer, or carcinoma in suit
Other
- Patients with distance metastasis (including ovarian and para-aortic lymph node metastasis)
Who the study is looking for
- 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):
- 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
Age in the registry: 20 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.