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The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.
For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc.
In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Other | Patients receive cisplatin IV over 60-90 minutes on days 1, 8, 15, 22, and 29. Patients also undergo external-beam radiation therapy once daily, 5 days a week, for approximately 5 weeks. Patients then undergo high-dose rate intracavitary brachytherapy. |
|
| experimental group | Experimental | Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug |
| ||
| External Beam Radiation Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | Described with Kaplan-Meier curves and unadjusted logrank tests. | at 3 years |
| disease free survival rate | at 3 years | |
| non-distant metastasis survival rate | at 3 years | |
| survival period of non-progressive. | at 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 3 years | |
| Radiation protocol compliance | 3 years | |
| Rate of acute and long-term toxicities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Shi, MD | Contact | 0086-029-84775432 | mshi82@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Mei Shi, MD | department of radiation oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| Radiation |
|
| Internal Radiation Therapy | Radiation |
|
| nimotuzumab | Drug |
|
| 3 years |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| C501466 | nimotuzumab |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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