Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy

Launched by SAMSUNG MEDICAL CENTER · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different types of radiation therapy for women with high-risk cervical cancer after having surgery to remove their uterus (called radical hysterectomy). The trial aims to compare traditional radiation therapy with a newer method called hypofractionated radiation therapy, which gives a higher dose of radiation over fewer sessions. Researchers want to see how effective these treatments are in improving patient outcomes and managing side effects.

To participate, women aged 20 to 75 who have been diagnosed with specific types of cervical cancer and have already had surgery may be eligible. They should also have certain health conditions that indicate the need for radiation therapy after surgery. Participants will receive either the conventional or hypofractionated radiation therapy along with chemotherapy and will be monitored for their treatment experience and any side effects. This study will help to provide more information on the best ways to treat cervical cancer and improve patient care.

Gender

FEMALE

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