Cervical cancer
Conditions
Interventions
paclitaxel(175mg/m2) carboplatin(AUC=5) bevacizumab(15mg/kg) Total 6 cycles administered every 3weeks.
Sponsors
University of the Ryukyus
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patient who are informed consent about participation in this study and received written consent. 2.ECOG Performance Status: 0-1 3.Cervical cancer stage IB-IIB(FIGO2008) 4.Patients who undergo radical hysterectomy and have one or more of the following conditions under postoperative pathological findings. (1)The depth of cervical stromal infiltrate exceeds 2/3. (2)The depth of cervical stromal infiltration ranges from 1/3 to 2/3 and lymph-vascular invasion positive. (3)Pelvic lymph node metastasis positive. (4)Resection margin positive. 5. Patients without residual lesions after surgery. 6. Patients without prior treatment other than surgery. 7. Patients who are expected to begin chemotherapy within 6 weeks after surgery. 8. Patients whose main organs (bonemarrow,heart,liver,kidney,etc.) function are preserved.
Exclusion criteria
Exclusion criteria: 1. Patients whose pathologically confirmed para aortic lymph node (PAN) metastasis. Patients who are suspected of PAN metastasis by preoperative imaging (CT with a short diameter of 10mm or more, suspicious metastasis with PET/CT, can't be registered if pathological negative is not confirmed. 2. Patients with active double cancer (synchronous double cancer and metachronous double cancer with disease-free period within 5 years). 3. Patient who have been treated with anti-VEGF and anti-VEGFR formulations. 4. Patients with symptomatic cerebrovascular disorders. 5. Patients with a high probability of bleeding due to congenital hemorrhagic diathesis, abnormal coagulation, etc. 6. Patients with severe cardiovascular disorders (such as poor control hypertension). 7. Patients with clinical symptoms of intestinal obstruction. 8. Patients with infection requiring systemic administration such as antibiotics, antivirals, antifungal drugs at registration. 9. Patients who received radiotherapy or chemotherapy before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year relapse-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event occurrence rate Chemotherapy completion rate 5 year overall survival rate 5 year relapse-free survival rate | — |
Countries
Japan
Contacts
Public ContactWataru Kudaka
University of the Ryukyus Hospital Obstetrics and gynecology
Outcome results
None listed