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The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.
This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group. |
|
| control group | Active Comparator | Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43. |
|
| Measure | Description | Time Frame |
|---|---|---|
| progress free survival rate | The rate of patient without progress disease in 3 years after treatment | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | The rate of patient alive in 3 years after treatment | 3 years |
| Local area control rate. | The rate of patient without recurrence in 3 years after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| junguo bu, doctor | Contact | +86 13729810406 | bujunguo888@163.com | |
| jiqiang li, doctor | Contact | +86 13631317203 | 13631317203@163.com |
| Name | Affiliation | Role |
|---|---|---|
| junguo bu, doctor | Zhujiang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital | Recruiting | Guangzhou | Guangdong | 510282 | China |
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| Cisplatin | Drug | Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks |
|
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| external-beam radiation | Radiation | Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy |
|
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| brachytherapy | Radiation | high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy |
|
|
| 3 years |
| No distant metastatic survival. | The rate of patient without metastatic disease in 3 years after treatment | 3 years |
| objective response rate | the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment. | 3 years |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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