Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer
Recruiting
Phase 3Interventional Study
Cervical Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
455 (estimated)
Sponsor
Zhejiang Cancer Hospital · Other
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* The patients voluntarily participated in the study and signed the informed consent
* 18-75 female
* Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
* According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2…
Inclusion Criteria:
* The patients voluntarily participated in the study and signed the informed consent
* 18-75 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 Criteria:
* 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
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