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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
455
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, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
ACTIVE_NOT_RECRUITINGJinhua Municipal Central Hospital Medical Group
Jinhua, China
Progression-free survival rate
the percentage of participants in the group whose disease is likely to remain stable
Time frame: 3-year
Overall survival rate
the percentage of participants in the group who survives
Time frame: 3-year
Para-aortic recurrence rate
the percentage of participants involved by recurrence in the area of para-aortic lymph node
Time frame: 3-year
Distant recurrence rate
the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area
Time frame: 3-years
Side effects
side effects associated with treatment
Time frame: 3-year
Quality of life (QOL) assessed by EORTC QLQ-C30 v3
an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-C30 v3 )
Time frame: 1-month and 6-month
Quality of life (QOL) assessed by EORTC QLQ-CX24
an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns (assessed by EORTC QLQ-CX24)
Time frame: 1-month and 6-month
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Lishui People's Hospital
Lishui, China
ACTIVE_NOT_RECRUITINGNingbo First Hospital
Ningbo, China
ACTIVE_NOT_RECRUITINGTaizhou Central Hospiatl
Taizhou, China
ACTIVE_NOT_RECRUITINGChongqing University Three Gorges Hospital
Wanzhou, China
ACTIVE_NOT_RECRUITING