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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.
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 â…¡ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Patients in this arm will postoperatively receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3 intravenously every 4 weeks with radiation. Radiotherapy consisted of 46-50 gray (5 x 2.0 gray/week) on pelvic area. After completion of chemoradiotherapy, patients receive paclitaxel 135 mg/m2 d1 and cisplatin 25mg/m2 d1-3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. |
|
| Arm 2 | Active Comparator | Patients receive chemoradiotherapy as in arm 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paclitaxel | Drug |
| ||
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | assessed by NCI Common Terminology Criteria v3.0 | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| congying xie, MD | Contact | +86-577-88069316 | wzxiecongying@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wenzhou Medical College | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| radiotherapy | Radiation |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |