Cervical cancer
Conditions
Interventions
Case series:Albumin Paclitaxel and Cisplatin Chemotherapy Combined with Synchronous Local Radiotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed cervical cancer, no previous history of radiotherapy and chemotherapy; 2) General condition and Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 3) Non-bed woman, aged 18 to 70 years; 4) According to FIGO guidelines, radical surgery and pelvic lymphadenectomy and no residue of IB-IIA cervical cancer patients; 5) At least the following high-risk factors exist after surgery: deep interstitial infiltration (invasion depth greater than 1/2 of vaginal wall thickness), pelvic lymph node positive, parametrial infiltration, lymphatic vessel infiltration, tumor diameter > 4cm; 6) The baseline blood routine examination and biochemical parameters of the subjects met the following criteria: WBC>3.5×10^9/L, ANC>1.5×10^9/L, Hb=100g/L, PLT=100×10/L, serum bilirubin=1.5×institutional upper limit of normal (ULN), AST and ALT=2.5×ULN,creatinine=1.0×ULN; 7) Enrolled within 3 months after surgery; 8) No other history of malignancy; 9) Provide written informed consent prior to entering the study screening, and the patient can withdraw at any time during the study without any loss; 10) Women of childbearing age must undergo a pregnancy test (serum or urine) 7 days befroe enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last dose; 11) The expected survival = 3 months; 12) Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant or breast-feeding during their reproductive period without effective contraception; 2) Have received anti-cancer treatment before enrollment; 3) Have had other malignant tumors at the same time ,except for cured skin basal cell carcinoma; 4) Metastasis, para-aortic lymph node positive, marginal invasion, second primary tumor; 5)Serious, uncontrolled medical conditions and infections; severe cardiovascular disease; 6) Major organ failure, such as decompensated cardiopulmonary liver and kidney failure; 7) Participated in another clinical trial within 4 weeks before the start of treatment; 8) Have contraindications for radiotherapy/chemotherapy; 9) Active HBV or HCV; 10) Peripheral neuropathy NCT-CTCAE=2 ; 11) Allergic to albumin-bound paclitaxel or cisplatin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD; | — |
Countries
China
Contacts
Public ContactYali Shen
West China Hospital, Sichuan University
Outcome results
None listed