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Clinical Trials in China / NCT04974346
Recruiting Phase 3

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

NCT04974346 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang Cancer Hospital
Phase
Phase 3
Started
2021-08-02
Last updated
2022-01-25

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiationPelvic definitive concurrent chemoradiation

Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation: The para-aortic area, from left renal vein level to abdominal aorta bifurcation level,will be prophylactic irradiation. The other intervention is the same as control arm.

Pelvic definitive concurrent chemoradiation: Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Zhejiang Cancer Hospital Hangzhou Zhejiang 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
Chongqing University Three Gorges Hospital Wanzhou China Active Not Recruiting

More Zhejiang Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04974346 on ClinicalTrials.gov ↗ ← All trials in China