To investigate the value of prophylactic extended-field irradiation (EFI), we conduct a randomized clinical trial to compare the efficacy and toxicity of pelvic irradiation and prophylactic EFI in selected patients with cervical cancer treated with definitive concurrent chemoradiotherapy. External beam radiation therapy is delivered with intensity-modulated radiation therapy (IMRT).
This is a multicenter, open-label, phase III randomized clinical trial. Cervical cancer patients without evidence of para-aortic metastatic lymph nodes (MLNs) and with at least one of the following characteristics are included in the present study: (a) Number of pelvic MLNs ≥ 2; (b)Short diameter of pelvic MLNs ≥ 1.5cm; (c)Pelvic wall involvement. Patients are randomly assigned to pelvic irradiation group and prophylactic EFI group. Patients in pelvic irradiation group receive pelvic irradiation, intracavitary brachytherapy and concurrent chemotherapy. Patients in prophylactic EFI group receive irradiation for pelvis and para-aortic lymph nodes region, intracavitary brachytherapy and concurrent chemotherapy. The upper border of clinical target volume (CTV) is at the level of renal vessels for patients in prophylactic EFI group. A dose of 45-50.4 Gy is delivered to CTV with IMRT in both groups. Patients receive cisplatin based concurrent chemotherapy (single cisplatin or cisplatin plus paclitaxel). The primary endpoint is progression-free survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
638
CTV covers pelvis and para-aortic lymph nodes region.
CTV covers pelvis.
The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGFirst Affiliated Hospital Xi'an Jiaotong University
Xi’an, Shanxi, China
RECRUITINGProgression-free survival
Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first.
Time frame: 3-year
Overall survival
Overall survival is calculated from randomization to death from any cause.
Time frame: 3-year
Distant failure-free survival
Distant failure-free survival is defined as the time from randomization to distant metastasis or death from any cause, whichever is first.
Time frame: 3-year
Para-aortic lymph nodes failure rate
The incidence of para-aortic lymph nodes failure.
Time frame: 3-year
Acute toxicity evaluated with CTCAE 5.0
Evaluated with CTCAE 5.0
Time frame: From the start of treatment to 3 months after treatment.
Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
Time frame: 3-year
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Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.