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Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

RECRUITINGPhase 3Sponsored by Zhejiang Cancer Hospital
Actively Recruiting
PhasePhase 3
SponsorZhejiang Cancer Hospital
Started2021-08-02
Est. completion2028-08-01
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions2

CancerCervical Cancer

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