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

Neoplasms Clinical Trial

Official title:

Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469531
• Other study ID #: 2017-ZLZX-002
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2018
• Source: Zhujiang Hospital
• Contact: junguo bu, doctor
• Phone: +86 13729810406
• Email: bujunguo888[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Carcinoma, Adenosquamous
• Carcinoma, Squamous Cell
• Cervical Adenosquamous Cell Carcinoma
• Cervical Squamous Cell Carcinoma in Situ
• Neoplasms
• Stage IB Cervical Cancer
• Stage IIA Cervical Cancer
• Stage IIB Cervical Cancer
• Stage III Cervical Cancer
• Stage IVA Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Nimotuzumab
Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
• Cisplatin
Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks

Radiation:
• external-beam radiation
Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
• brachytherapy
high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progress free survival rate	The rate of patient without progress disease in 3 years after treatment	3 years
Secondary	Overall survival rate	The rate of patient alive in 3 years after treatment	3 years
Secondary	Local area control rate.	The rate of patient without recurrence in 3 years after treatment	3 years
Secondary	No distant metastatic survival.	The rate of patient without metastatic disease in 3 years after treatment	3 years
Secondary	objective response rate	the percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.	3 years