Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
Zhejiang Cancer Hospital
455 participants
Aug 2, 2021
INTERVENTIONAL
Conditions
Summary
Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.
Eligibility
Inclusion Criteria9
- The patients voluntarily participated in the study and signed the informed consent
- female
- Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
- According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2 - ⅣA with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT
- Cisplatin chemotherapy is acceptable
- Eastern Cooperative Oncology Group(ECOG) score 0-1
- The expected survival was more than 6 months
- Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test
- According to the judgment of the researcher, those who can comply with the trial protocol
Exclusion Criteria12
- Uncontrolled severe infection
- Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years
- The patient has received anti-tumor treatment
- Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure
- History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease
- Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (NYHA classification)
- Patients with previous pelvic artery embolization
- Previous radiotherapy for pelvic malignant tumor
- There was a history of severe allergic reaction to platinum containing chemotherapy drugs
- Complications, need to be taken during the treatment of liver and kidney function damage drugs, such as tuberculosis
- The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent
- Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study
Interventions
The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.
Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT04974346