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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Cisplatin; Radiation: External Beam Radiation Therapy; Radiation: Internal Radiation Therapy; Drug: nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02705612

XJFL-2016-02-LACC-Nimotuzumab

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

control group

Other group

Description:

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.

Treatment:

Radiation: External Beam Radiation Therapy

Radiation: Internal Radiation Therapy

Drug: Cisplatin

experimental group

Experimental group

Description:

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

Treatment:

Radiation: External Beam Radiation Therapy

Drug: nimotuzumab

Radiation: Internal Radiation Therapy

Drug: Cisplatin