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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02705612
• Other study ID #: XJFL-2016-02-LACC-Nimotuzumab
• Status: Recruiting
• Phase: Phase 2
• First received: March 5, 2016
• Last updated: March 9, 2016
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: March 2016
• Source: Fourth Military Medical University
• Contact: Mei Shi, MD
• Phone: 0086-029-84775432
• Email: mshi82[@]fmmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Cisplatin

Radiation:
• External Beam Radiation Therapy

• Internal Radiation Therapy

Drug:
• nimotuzumab

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	Described with Kaplan-Meier curves and unadjusted logrank tests.	at 3 years	No
Primary	disease free survival rate		at 3 years	No
Primary	non-distant metastasis survival rate		at 3 years	No
Primary	survival period of non-progressive.		at 3 years	No
Secondary	Quality of life		3 years	No
Secondary	Radiation protocol compliance		3 years	No
Secondary	Rate of acute and long-term toxicities		3 years	Yes