Cervical Cancer
Conditions
Keywords
locally advanced cervical cancer, para-aortic radiotherapy, concurrent radiochemotherapy, PET-CT
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.
Interventions
RADIATIONParaaortic 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.
RADIATIONPelvic definitive concurrent chemoradiation
Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival rate | 3-year | the percentage of participants in the group whose disease is likely to remain stable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | 3-year | the percentage of participants in the group who survives |
| Para-aortic recurrence rate | 3-year | the percentage of participants involved by recurrence in the area of para-aortic lymph node |
| Quality of life (QOL) assessed by EORTC QLQ-C30 v3 | 1-month and 6-month | 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 ) |
| Side effects | 3-year | side effects associated with treatment |
| Quality of life (QOL) assessed by EORTC QLQ-CX24 | 1-month and 6-month | 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) |
| Distant recurrence rate | 3-years | the percentage of participants involved by recurrence in any organ or tissue except pelvic and para-aortic area |
Countries
China
Contacts
Primary ContactXiang Zhang
Outcome results
None listed