Compares two radiation schedules after surgery for high-risk cervical cancer
Tests shorter, higher-dose radiation against standard radiation in women with high-risk cervical cancer.
Plain-language title generated from the registry record
Registry title: Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 75 years old?
Source: NCT06509724, who can take part
Where in South Korea
- Samsung Medical CenterSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Samsung Medical Center
- Trial code
- NCT06509724
- Record updated
- 26 July 2024
- Original description
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.Read full original descriptionShow less
Postoperative Conventional Versus Hypofractionated Intensity-modulated Radiation Therapy With Concurrent Chemotherapy in Cervical Cancer: A Prospective Multicenter Randomized Phase III Trial (POHIM_P3 Trial)
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.
Inclusion: 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.
Exclusion: 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; 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; Patients with distance metastasis (including ovarian and para-aortic lymph node metastasis).