Locally Advanced Cervical Cancer
Conditions
Keywords
surgery staging, image staging, Locally advanced cervical cancer, PFS
Brief summary
The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.
Detailed description
All eligible patients will be divided into the following two treatment groups nonrandomly. Image staging group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy). Surgery staging group: open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be conducted within 28 days postoperatively.)
Interventions
RADIATIONConcurrent chemoradiation
Standard concurrent chemoradiation: A point/HCR-CTV D90 ≥80Gy (+20%) by using IMRT or TOMO technics. Patients with image-positive common iliac lymph nodes or para-aortic lymph nodes receive extended-field EBRT. Brachytherapy should begin after 15-20F external radiotherapy. A radiation dose for the image-positive nodes can range from 55Gy to 60Gy. Five cycles of concurrent platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period one week) and CCRT should be completed within 56 days. CCRT one week later, if the cervix biopsy shows residual tumour and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes in the pelvic and abdominal cavity, three cycles of adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy will be performed (A point/HR-CTV D90 ≤ 96Gy).
PROCEDUREOpen/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (height of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation should be performed postoperatively within 28 days.) The chemoradiation is consistent with the image staging group, except for extended-field EBRT determined by pathological positive para-aortic lymph nodes.
Sponsors
Chongqing University Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a non-randomized controlled concurrent trial. According to the patients' voluntary choice, they are enrolled on the surgery staging group or image staging group. All patients are evaluated by CT(≥32 slices) or MRI(≥1.5T) or PET/CT. The criteria for positive pelvic or para-aortic lymph nodes (one of the following): ① CT or MRI show more than one positive lymph node with a short diameter ≥ 15mm; ② PET/CT shows more than one positive lymph node with SUV ≥ 2.5; ③ If CT or MRI show positive lymph node with a short diameter between 10mm and 15mm, PET / CT should further verify that it is a positive lymph node with SUV ≥ 2.5.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The patients with good compliance, voluntarily signed the informed consent form and participated in the study. 2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma 3. Stage (FIGO2018): IB3, IIA2, IIB-IVA; 4. ECOG score: 0 \ 1; 5. The expected survival \>6 months; 6. The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.
Exclusion criteria
1. Activity or uncontrol severe infection; 2. Liver cirrhosis or other decompensated liver disease; 3. A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease; 4. Chronic renal insufficiency or renal failure; 5. Other malignancies were diagnosed within five years or needed treatments; 6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association); 7. The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive; 8. A history of pelvic artery embolization; 9. A history of pelvic radiotherapy; 10. A history of partial hysterectomy or radical hysterectomy; 11. A history of severe allergic reaction to platinum drugs; 12. The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis; 13. Patients who cannot understand the research regimen and refuse to sign the informed consent form; 14. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3 years | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 3 years and 5 years | 3-year and 5-year Overall Survival |
| Complication | 1 year | Some conditions caused by surgery or chemoradiation. |
Countries
China
Contacts
Primary ContactDongling Zou, M.D.
Outcome results
None listed