Cervical Cancer
Conditions
Keywords
Cervical cancer, cisplatin, nimotuzumab
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.
Interventions
DRUGCisplatin
RADIATIONExternal Beam Radiation Therapy
RADIATIONInternal Radiation Therapy
DRUGnimotuzumab
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival rate | at 3 years | Described with Kaplan-Meier curves and unadjusted logrank tests. |
| disease free survival rate | at 3 years | — |
| non-distant metastasis survival rate | at 3 years | — |
| survival period of non-progressive. | at 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiation protocol compliance | 3 years |
| Rate of acute and long-term toxicities | 3 years |
| Quality of life | 3 years |
Countries
China
Contacts
Primary ContactMei Shi, MD
Outcome results
None listed