Uterine Cervical Neoplasms
Conditions
Keywords
Uterine Cervical Neoplasms, Extended-field irradiation
Brief summary
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).
Detailed description
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.
Interventions
RADIATIONProphylactic extended-field Irradiation
CTV covers pelvis and para-aortic lymph nodes region.
RADIATIONPelvic irradiation
CTV covers pelvis.
RADIATIONIntracavitary brachytherapy
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.
DRUGConcurrent chemotherapy
Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.
Sponsors
Peking University First Hospital
Cangzhou Central Hospital
The Second Affiliated Hospital of Dalian Medical University
Gansu Wuwei Tumor Hospital
First Affiliated Hospital of Guangxi Medical University
Harbin Medical University Third Affiliated Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
First Affiliated Hospital of Chongqing Medical University
Guizhou Provincial People's Hospital
Second Hospital of Jilin University
China-Japan Union Hospital, Jilin University
Jilin Provincial Tumor Hospital
Jiangsu Cancer Institute & Hospital
940 Hospital of the People's Liberation Army Joint Logistic Support Force
General Hospital of Benxi Iron & Steel Industry Group
The Affiliated Hospital of Inner Mongolia Medical University
General Hospital of Ningxia Medical University
Beijing Obstetrics and Gynecology Hospital
Tangshan People's Hospital
Zhongnan Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Tumor Hospital of Xinjiang Medical University
Zhejiang Cancer Hospital
The First Affiliated Hospital of Zhengzhou University
Affiliated Cancer Hospital of Zhengzhou University
Seventh Medical Center of PLA Army General Hospital
Shengjing Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Xiangya Hospital of Central South University
Henan Provincial People's Hospital
Xi'an Gaoxin Hospital
West China Second University Hospital
The Forth Affiliated Hospital of Guangxi Medical University
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be informed of the investigational nature of this study and give written informed consent with 30 days before treatment. 2. Age ≥18 years and ≤ 70 years. 3. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al. 4. No evidence of para-aortic metastatic lymph nodes (MLNs) on CT, MRI or positron emission tomograph (PET)/CT.\* 5. No evidence of distant metastasis (FIGO stage IVB). 6. At least meet one of the following characteristics: 1. Number of pelvic MLNs ≥ 2; 2. Short diameter of pelvic MLNs ≥ 1.5cm; \* 3. Parametrial involvement to the pelvic wall ＃. 7. Satisfactory performance: Eastern Cooperative Oncology Group (ECOG) score ≥ 2. 8. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L. 9. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN). * MLNs refer to positive lymph nodes confirmed by PET/CT or lymph nodes with short diameter ≥ 1 cm on CT or MRI. * Parametrial involvement to the pelvic wall is diagnosed with gynecological examination or MRI;
Exclusion criteria
1. With common iliac MLNs. 2. Tumor extended to the lower third of the vagina. 3. Tumor spread to mucosa of the bladder or rectum. 4. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes. 5. Prior malignancy. 6. History of previous radiotherapy to the abdomen or pelvis. 7. Pregnancy or lactation. 8. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer. 9. Active infection with fever. 10. Patients with unacceptable risk that intracavitary brachytherapy can not be conducted. 11. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3-year | Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever is first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3-year | Overall survival is calculated from randomization to death from any cause. |
| Distant failure-free survival | 3-year | Distant failure-free survival is defined as the time from randomization to distant metastasis or death from any cause, whichever is first. |
| Para-aortic lymph nodes failure rate | 3-year | The incidence of para-aortic lymph nodes failure. |
| Acute toxicity evaluated with CTCAE 5.0 | From the start of treatment to 3 months after treatment. | Evaluated with CTCAE 5.0 |
| Late toxicity evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme | 3-year | Evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme |
Countries
China
Contacts
Primary ContactKe Hu
Outcome results
None listed