Cervical Cancer
Conditions
Keywords
cervical cancer, radiotherapy, postoperative therapy, chemotherapy
Brief summary
This phase III study is designed to examine if low-risk (lymph node negative), stage I a2-II b cervical cancer patients treated by paclitaxel/cisplatin chemoradiation have greater toxicities but similar survival rate as those treated by radiotherapy alone.
Detailed description
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.
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 (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
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