Actively Recruiting
Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
Led by Samsung Medical Center · Updated on 2024-07-26
248
Participants Needed
1
Research Sites
441 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Conventional and Hypofractionated IMRT in High-Risk Cervical Cancer Post-Radical Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with cervical cancer confirmed by tissue examination
- Diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
- Have undergone radical hysterectomy and pelvic lymph node removal
- Have at least one of the following in postoperative pathology: pelvic lymph node metastasis, parametrial involvement, or positive surgical margins
- Aged 20 to 75 years
- Have an ECOG performance status of 0 or 1 within 1 week before joining the study
- Have maintained bone marrow function (granulocytes ≥1.0 x 10^3/µl, platelets ≥30 x 10^3/µl, hemoglobin ≥9.5 g/dl)
- Have maintained kidney and liver function (creatinine <2.0 mg/dL, bilirubin <1.5 mg/dl)
- Have voluntarily signed the consent form
You will not qualify if you...
- Have distant metastasis including ovarian and para-aortic lymph node metastasis
- Have previously received radiation therapy to the pelvic area
- Had radical hysterectomy more than 3 months ago
- Have untreated serious acute illnesses such as stroke, cerebral infarction, or myocardial infarction except cervical cancer
- Received chemotherapy before surgery (neoadjuvant chemotherapy)
- Will not receive chemotherapy during radiation therapy
- Have had another cancer diagnosis in the past 5 years, except thyroid cancer, skin cancer, or carcinoma in situ
AI-Screening
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Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 06351
Actively Recruiting
Research Team
W
Won Park, M.D.,Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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