RecruitingPhase 3NCT06509724

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)

Sponsor

Samsung Medical Center

Enrollment

248 participants

Start Date

Jul 19, 2024

Study Type

INTERVENTIONAL

Conditions

Uterine Cervical Neoplasms

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

Sex: FEMALEMin Age: 20 YearsMax Age: 75 Years

Inclusion Criteria10

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 Criteria7

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