Cervical Cancer
Conditions
Keywords
cervical cancer, radiotherapy, postoperative therapy, chemotherapy
Brief summary
The purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.
Detailed description
Cervical carcinoma is one of the most common gynecologic cancers worldwide. Early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. However, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis. Concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. However, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. How to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation. Paclitaxel has been demonstrated to be a good radiosensitizer. In addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase Ⅱ studies. In addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer. Therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk patients with early-stage cervical cancer following radical hysterectomy.
Interventions
DRUGpaclitaxel
DRUGcisplatin
RADIATIONradiotherapy
Sponsors
xie congying
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Undertaken radical hysterectomy with diagnosis of invasive cervical cancer I a2-II b (non-small cell type) * One or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement) * Eastern Cooperative Oncology Group 0-2 * Expected life span over 6 months. * No distant metastasis * Adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl) * Adequate renal functions(serum creatinine ≤ 1.5mg/dl) * Adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value) * Written informed consent
Exclusion criteria
* Previous history of chemotherapy or radiation * Hypersensitive reaction to platinum/paclitaxel agent * History of other cancer * Concurrent systemic illness not appropriate for chemotherapy * Active infection requiring antibiotics * Pregnancy * Metastasis to paraaortic lymph node
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| overall survival | 5 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | 1 year | assessed by NCI Common Terminology Criteria v3.0 |
Countries
China
Contacts
Primary Contactcongying xie, MD
Outcome results
None listed