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Trial Title:
Trial of Postoperative Chemoradiotherapy With or Without Consolidation Chemotherapy for Cervical Cancer Patients
NCT ID:
NCT01755845
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Cisplatin
Conditions: Keywords:
cervical cancer
radiotherapy
postoperative therapy
chemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
paclitaxel
Arm group label:
Arm 1
Arm group label:
Arm 2
Intervention type:
Drug
Intervention name:
cisplatin
Arm group label:
Arm 1
Arm group label:
Arm 2
Intervention type:
Radiation
Intervention name:
radiotherapy
Arm group label:
Arm 1
Arm group label:
Arm 2
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical College
Address:
City:
Wenzhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
congying xie
Phone:
+86-577-88069316
Email:
wzxiecongying@163.com
Investigator:
Last name:
congying xie, MD
Email:
Principal Investigator
Start date:
January 2011
Completion date:
December 2016
Lead sponsor:
Agency:
xie congying
Agency class:
Other
Source:
Wenzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01755845
