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.
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
Adult aged 20 to 75 years
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
Parallel
Conventional Fractionated IMRT
Radiation* Dose: 1.8-2.0 Gy per session, total 25-28 sessions (40-50.4Gy) * Chemotherapy: Weekly, total 5-6 sessions
Hypofractionated IMRT
Radiation* Dose: 2.5 Gy per session, total 16 sessions (40Gy) * Chemotherapy: Weekly, total 3 sessions
Local control rate for the radiation treatment area
The percentage of patients who achieve local control of their cervical cancer within the radiation treatment area. Local control is defined as the absence of tumor recurrence or progression in the region.
Overall survival (OS)
The duration of time from the date of randomization until death from any cause. This measure will evaluate the effectiveness of the treatment in prolonging life.
Disease-free survival (DFS)
The length of time from the date of randomization until the occurrence of any signs or symptoms of cervical cancer, such as local recurrence, distant metastasis, or secondary cancer. This measure assesses the efficacy of the treatment in preventing cancer recurrence.
Acute Toxicity Profile
The incidence and severity of acute treatment-related toxicities, as measured by the Common Terminology Criteria for Adverse Events (CTCAE). Acute toxicities are those occurring within 90days of the start of treatment.
Late Toxicity Profile
The incidence and severity of late treatment-related toxicities, as measured by the Common Terminology Criteria for Adverse Events (CTCAE). Late toxicities are those occurring more than 90 days after the completion of treatment.
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