Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: Cisplatin
* Radiation: External Beam Radiation Therapy
* Radiation: Internal Radiation Therapy
* Drug: nimotuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years to 70 Years，female Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis. no chance of surgery confirmed by more than two deputy chief doctors of gynecology. Moderate or high expression of EGFR The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment. WBC≥3.5×10E9/L，ANC≥1.5×10E9/L；HB≥90g/L，PLT≥100×10E9/L ALT, AST and Cr below 1.5 times of normal level Willing to accept treatment Ability to comply with trial requirements KPS≥70 Exclusion Criteria: Evidence of distance metastasis Impossible to measure the diameter of tumor, or the tumor is too huge (diameter>6cm) Couldn't examine with pelvic MRI due to a variety of reasons Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy Diagnosed with another malignant tumor in 5 years Used to be a volunteer of other clinical trial. Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs Severe medical history of lung ,liver, kidney or heart. Active infection in any part of the whole body. Examination results showed radiotherapy contraindications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control group<br>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. | Drug: Cisplatin<br> <br> Radiation: External Beam Radiation Therapy<br> <br> Radiation: Internal Radiation Therapy<br> <br> |
| Experimental: experimental group<br>Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy. | Drug: Cisplatin<br> <br> Radiation: External Beam Radiation Therapy<br> <br> Radiation: Internal Radiation Therapy<br> <br> Drug: nimotuzumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 3 years | 
| Radiation protocol compliance |  | 3 years | 
| Rate of acute and long-term toxicities |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, cisplatin, nimotuzumab