Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Phase 2

• Conditions: Stage III Cervical Cancer; Stage IVA Cervical Cancer; Cervical Adenosquamous Cell Carcinoma; Cervical Squamous Cell Carcinoma in Situ; Stage IB Cervical Cancer; Stage IIB Cervical Cancer; Neoplasms; Stage IIA Cervical Cancer
• Interventions: Drug: Nimotuzumab; Drug: Cisplatin; Radiation: external-beam radiation; Radiation: brachytherapy

• Registration Number: NCT03469531
• Lead Sponsor: Zhujiang Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-19
• Study Start: 2018-03-20
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13
• Primary Completion: 2021-03-10
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• All volunteers will sign the informed consent.
• Histologically confirmed squamous cell of the uterine cervix, EGFR(+).
• The FIGO stage (IIB-IVA) and was not available for surgical treatment.
• There is at least one tumor lesion that is measurable by RECIST.
• During the study, contraception should be ensured.
• Karnofsky performance status >60.
• WBC >= 3,000/mm^3
• Absolute granulocyte count >= 1,500/mm^3
• Platelet count >= 100,000/mm^3
• INR < 1.5
• Total bilirubin =< 1.5 mg/dL
• Serum creatinine =< 1.5 mg/dL
• AST and ALT =< 2.5 times upper limit of normal (ULN)
• Serum calcium =< 1.3 times ULN
• Hemoglobin >= 9g/dL (transfusion allowed)

Exclusion Criteria

• Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic
• Prior invasive malignancy (except nonmelanomatous skin cancer)
• Contraindication of chemotherapy;
• Rare pathological subtype;
• Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	external-beam radiation	Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
experimental group	brachytherapy	Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
control group	external-beam radiation	Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
control group	brachytherapy	Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.
experimental group	Nimotuzumab	Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
experimental group	Cisplatin	Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.
control group	Cisplatin	Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.

Primary Outcome Measures

Name	Time	Method
progress free survival rate	3 years	The rate of patient without progress disease in 3 years after treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	3 years	The rate of patient alive in 3 years after treatment
No distant metastatic survival.	3 years	The rate of patient without metastatic disease in 3 years after treatment
Local area control rate.	3 years	The rate of patient without recurrence in 3 years after treatment
objective response rate	3 years	the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.

Trial Locations

Locations (1)

Zhujiang Hospital; 🇨🇳 Guangzhou, Guangdong, China