Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

Recruiting now · Phase 3

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT04974346

Run by

Zhejiang Cancer Hospital

People needed

455

Starts

2021-08-02

Expected to finish

2030-08-01

Last updated by the study team

2022-01-25

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (enrolling)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China
• Jinhua Municipal Central Hospital Medical Group — Jinhua, China
• Lishui People's Hospital — Lishui, China
• Ningbo First Hospital — Ningbo, China
• Taizhou Central Hospiatl — Taizhou, China
• Chongqing University Three Gorges Hospital — Wanzhou, China

Full record on ClinicalTrials.gov

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