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

Phase 2

• Conditions: Cervical Cancer
• Interventions: Drug: Cisplatin; Radiation: External Beam Radiation Therapy; Radiation: Internal Radiation Therapy; Drug: nimotuzumab

• Registration Number: NCT02705612
• Lead Sponsor: Air Force Military Medical University, China

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-09
• Status Verified: 2016-03
• Study First Submitted: 2016-03-05
• Study First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10
• Primary Completion: 2016-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	External Beam Radiation Therapy	Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.
experimental group	Internal Radiation Therapy	Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.
experimental group	Cisplatin	Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.
control group	External Beam Radiation Therapy	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.
control group	Internal Radiation Therapy	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.
control group	Cisplatin	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.
experimental group	nimotuzumab	Patients receive cisplatin and undergo external-beam radiation and brachytherapy as the patients in control group. Patients also receive nimotuzumab during the external radiotherapy.

Primary Outcome Measures

Name	Time	Method
Overall survival rate	at 3 years	Described with Kaplan-Meier curves and unadjusted logrank tests.
non-distant metastasis survival rate	at 3 years
survival period of non-progressive.	at 3 years
disease free survival rate	at 3 years

Secondary Outcome Measures

Name	Time	Method
Radiation protocol compliance	3 years
Rate of acute and long-term toxicities	3 years
Quality of life	3 years

Trial Locations

Locations (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China