Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

  • STATUS
    Recruiting
  • End date
    Aug 1, 2030
  • participants needed
    455
  • sponsor
    Zhejiang Cancer Hospital
Updated on 1 August 2021
carcinoma
squamous cell carcinoma
metastasis
brachytherapy
adenocarcinoma
pet/ct scan
concurrent chemoradiation

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.

Description

This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.

Details
Condition Cervical Cancer, Disorders of cervix NOS, Uterine Cancer, cervical carcinoma, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix
Treatment Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation, Pelvic definitive concurrent chemoradiation
Clinical Study IdentifierNCT04974346
SponsorZhejiang Cancer Hospital
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The patients voluntarily participated in the study and signed the informed consent
-75 female
Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage B2 - A 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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