Clinical trial NCT04974346: Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer
Official title: Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: locally advanced cervical cancer
para-aortic radiotherapy
concurrent radiochemotherapy
PET-CT
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 455
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Progression-free survival rate
timeFrame: 3-year
Secondary outcomes:
measure: Overall survival rate
timeFrame: 3-year
measure: Para-aortic recurrence rate
timeFrame: 3-year
measure: Distant recurrence rate
timeFrame: 3-years
measure: Side effects
timeFrame: 3-year
measure: Quality of life (QOL) assessed by EORTC QLQ-C30 v3
timeFrame: 1-month and 6-month
measure: Quality of life (QOL) assessed by EORTC QLQ-CX24
timeFrame: 1-month and 6-month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital Medical Group
city: Lishui
country: China
facility: Lishui People's Hospital
city: Ningbo
country: China
facility: Ningbo First Hospital
city: Taizhou
country: China
facility: Taizhou Central Hospiatl
city: Wanzhou
country: China
facility: Chongqing University Three Gorges Hospital
Study officials:
References: