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

Zhujiang Hospital

Status and phase: Unknown; Phase 2

Conditions: Stage IVA Cervical Cancer; Stage III Cervical Cancer; Stage IB Cervical Cancer; Neoplasms; Stage IIB Cervical Cancer; Stage IIA Cervical Cancer; Cervical Adenosquamous Cell Carcinoma; Cervical Squamous Cell Carcinoma in Situ

Treatments: Radiation: brachytherapy; Drug: Nimotuzumab; Drug: Cisplatin; Radiation: external-beam radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03469531

2017-ZLZX-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

experimental group

Experimental group

Description:

Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy as the patients in experimental group.

Treatment:

Radiation: external-beam radiation

Drug: Cisplatin

Drug: Nimotuzumab

Radiation: brachytherapy

control group

Active Comparator group

Description:

Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group.

Treatment:

Radiation: external-beam radiation

Drug: Cisplatin

Radiation: brachytherapy