Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
18 Years
75 Years
Female
Cervical Cancer
Trial Information
Phase III Randomized Trial of Comparing Chemoradiotherapy vs. Radiotherapy Alone in Lymph Node Negative Patients With Early-Stage Cervical Cancer Following Radical Hysterectomy
Cervical carcinoma is one of the most common gynecologic cancers worldwide. Concurrent
radiotherapy with cisplatin-based chemotherapy has become the standard treatment for
patients with high risk factors cervical cancer. However, the treatment modality in patients
with low-risk (lymph node negative) is still disputable. It is not yet known whether
cisplatin-based chemoradiotherapy are more effective than radiotherapy alone in treating
these patients.
Therefore, the investigators are going to perform the efficacy and safety study of
postoperative concurrent paclitaxel/cisplatin chemoradiotherapy vs. radiotherapy alone in
lymph node negative patients with early-stage cervical cancer following radical
hysterectomy.
Inclusion Criteria:
- Undertaken radical hysterectomy with diagnosis of invasive cervical cancer
(non-small cell type)
- Negative lymph node
- At least two risk factors (interstitial infiltration of greater than 1/3, vascular or
lymphatic involvement, cervix neoplasms larger than 4 cm, nerve 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
disease-free survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Congying Xie, MD
Investigator Role:
Study Director
Investigator Affiliation:
the 1st Affiliated Hospital of Wenzhou Medical College
Authority:
China: Food and Drug Administration
Study ID:
WZMC-11352
NCT ID:
NCT01756170
Start Date:
January 2011
Completion Date:
December 2016
Related Keywords:
- Cervical Cancer
- cervical cancer
- radiotherapy
- postoperative therapy
- chemotherapy
- Uterine Cervical Neoplasms
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