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Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
cervical cancer, radiotherapy, postoperative therapy, chemotherapy
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: paclitaxel
Type: Drug
Name: cisplatin
Type: Drug
Name: radiotherapy
Type: Radiation
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
- 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
Location
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Status: Recruiting
Contact: congying xie - +86-577-88069316 - wzxiecongying@163.com
Start Date
January 2011
Completion Date
December 2016
Sponsors
xie congying
Source
Wenzhou Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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