Status:
RECRUITING
Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
Lead Sponsor:
Samsung Medical Center
Conditions:
Uterine Cervical Neoplasms
Eligibility:
FEMALE
20-75 years
Phase:
PHASE3
Brief 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 hypofraction...
Detailed Description
* This phase 3 multicenter randomized controlled trial evaluates two radiation therapy regiments in high-risk cervical cancer patients who have undergone radical hysterectomy. Participants are randoml...
Eligibility Criteria
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):
- 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
- 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
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT06509724
Start Date
July 19 2024
End Date
December 31 2032
Last Update
July 26 2024
Active Locations (1)
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1
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 06351