Clinical trial NCT02705612: Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer
Official title: Efficacy and Safety of Radiotherapy Concurrently Combined With Cisplatin and Nimotuzumab for Patients With Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: Cervical cancer
cisplatin
nimotuzumab
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival rate
timeFrame: at 3 years
measure: disease free survival rate
timeFrame: at 3 years
measure: non-distant metastasis survival rate
timeFrame: at 3 years
measure: survival period of non-progressive.
timeFrame: at 3 years
Secondary outcomes:
measure: Quality of life
timeFrame: 3 years
measure: Radiation protocol compliance
timeFrame: 3 years
measure: Rate of acute and long-term toxicities
timeFrame: 3 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: department of radiation oncology
name: Mei Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: