Prophylactic irradiation for advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of para-aortic prophylactic radiotherapy in improving disease-free survival for patients with locally advanced cervical cancer who have positive pelvic lymph nodes. Participants will be randomly assigned to receive either para-aortic and pelvic radiotherapy combined with concurrent chemotherapy or pelvic radiotherapy alone with concurrent chemotherapy. The study aims to determine if the addition of para-aortic irradiation can lead to better outcomes compared to standard treatment. The trial includes women aged 18-75 with specific cancer types and staging criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, China Active not recruiting
• Jinhua Municipal Central Hospital Medical Group
  Jinhua, China Active not recruiting
• Lishui People's Hospital
  Lishui, China Active not recruiting
• Ningbo First Hospital
  Ningbo, China Active not recruiting
• Taizhou Central Hospiatl
  Taizhou, China Active not recruiting

Study contacts

• Study coordinator: Xiang Zhang
• Email: zhangxiang@zjcc.org.cn
• Phone: 0086-571-88122148

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.