cervical cancer
Conditions
Interventions
pelvic bone marrow sparing group:pelvic bone marrow sparing
control group:Pelvic bone marrow not sparing
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Histological diagnosis of the initial treatment of cervical squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma, the clinical stage is IIA2, IB3-IV.A stage (FIGO 2018 stage); 3. At least 1 measurable lesion according to RECIST 1.1 standard; 4. There are no serious hematopoietic abnormalities and abnormal heart, lung, liver, kidney function and immunodeficiency, and the laboratory test results meet the following criteria: 5 Hemoglobin >= 90g/L; ?Absolute neutrophil count>= 2×10^9/L or WBC count >= 4.0×10^9/L; ?Platelet count>= 100×10^9/L; ?Aminotransferase aspartate (AST) = 3 months; 7. Potentially fertile women are negative for serum or urine hCG within 72 hours before enrolment (postmenopausal women must be amenorrhea for at least 12 months to be considered infertile.) For women who have been shown to have undergone tubal ligation, a pregnancy test is not required. ) 8. Those without IUD; 9. Potentially fertile women are willing to use medically approved contraceptives in the trial; 10. Good compliance, voluntary signing of informed consent..
Exclusion criteria
Exclusion criteria: 1. Cervical cancer rarely pathological type malignant tumor; 2. Have previously undergone surgical treatment for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy; 3. Bilateral ureteral obstruction, can not be placed in a ureter stent or perform pyelostomy surgery; 4. Pregnant or lactating people; 5. Those with rectal vaginal fistula / vaginal bladder fistula / uncontrolled vaginal bleeding or the risk of fistula; 6. Human immunodeficiency virus (HIV) infection; 7. Active hepatitis B (HBV DNA quantitative test results exceed the lower limit of detection), or HCV infection (HCV RNA quantitative test results exceed the lower limit of detection); 8. Suffering from a serious underlying medical condition that makes it impossible to safely administer trial treatment. including but not limited to active infections requiring systemic therapy: self-compensated heart failure (NYHA graded III and IV), unstable angina, acute myocardial infarction within 3 months prior to enrollment; 9. Those with a history of other malignant tumors (except for the substrate cell carcinoma of the skin that has been cured); 10. People with Crohn's disease and ulcerative colitis; 11. Those who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks; 12. There are contraindications to cisplatin, paclitaxel; 13. Neurological or psychiatric abnormalities that affect cognitive ability; 14. Those who have been assessed by the investigator and are unable to perform intraluminal radiation therapy; 15. There are other reasons for which the researcher determines that it is not suitable for participation in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood routine examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum dose (Dmax) of bone marrow during radiotherapy;Minimum dose (Dmin) of bone marrow during radiotherapy;Mean dose (Dmean) of bone marrow during radiotherapy;The volume of bone marrow receiving 10~50Gy (V10~50);Dmax of plan target volume (PTV);Dmin of PTV;Dmean of PTV;The volume of PTV receiving 100% of the prescribed dose (V100%);conformity index (CI);homogeneity index (HI);Dmax of organs at risk (small intestine, rectum, bladder, left and right femoral heads);Dmin of organs at risk (small intestine, rectum, bladder, left and right femoral heads);Dmean of organs at risk (small intestine, rectum, bladder, left and right femoral heads);V10~50 of organs at risk (small intestine, rectum, bladder, left and right femoral heads);objective remission rate (ORR));Disease control rate (DCR);Radiation damage to the digestive system;Radiation injury to the urinary system; | — |
Countries
China
Contacts
Public ContactWang Yali
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed