Clinical trial NCT03469531: Study of Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
Official title: Efficacy and Safety of Nimotuzumab Combined With Radiotherapy and Concurrently Cisplatin in Patients With Stage IIB-IVA Cervical Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neoplasms
Cervical Adenosquamous Cell Carcinoma
Cervical Squamous Cell Carcinoma in Situ
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Keywords: Cervical Cancer
Radiation Therapy
Chemotherapy
Nimotuzumab
Cisplatin
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
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 combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical squamous cell carcinoma.

Detailed description: This phase II trial is studying how well giving nimotuzumab together with radiation therapy and cisplatin works in treating patients with previously untreated locally advanced cervical cancer. Monoclonal antibodies, such as nimotuzumab, a humanized anti-epidermal growth factor receptor (EGFR) monoclonal antibody that is approved in many countries for the treatment of EGFR-positive cancers. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Nimotuzumab also stop the growth of cervical cancer by increasing the effect of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nimotuzumab together with radiation therapy and cisplatin may kill more tumor cells.

Eligibility criteria: Inclusion Criteria:

* All volunteers will sign the informed consent.
* Histologically confirmed squamous cell of the uterine cervix, EGFR(+).
* The FIGO stage (IIB-IVA) and was not available for surgical treatment.
* There is at least one tumor lesion that is measurable by RECIST.
* During the study, contraception should be ensured.
* Karnofsky performance status \>60.
* WBC \>= 3,000/mm\^3
* Absolute granulocyte count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* INR \< 1.5
* Total bilirubin =\< 1.5 mg/dL
* Serum creatinine =\< 1.5 mg/dL
* AST and ALT =\< 2.5 times upper limit of normal (ULN)
* Serum calcium =\< 1.3 times ULN
* Hemoglobin \>= 9g/dL (transfusion allowed)

Exclusion Criteria:

* Positive para-aortic lymph nodes or positive lymph nodes beyond pelvic
* Prior invasive malignancy (except nonmelanomatous skin cancer)
* Contraindication of chemotherapy;
* Rare pathological subtype;
* Cervical cancer patients underwent hysterectomy, laparoscopic surgery or systemic chemotherapy.

Primary outcomes:
measure: progress free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival rate
timeFrame: 3 years
measure: Local area control rate.
timeFrame: 3 years
measure: No distant metastatic survival.
timeFrame: 3 years
measure: objective response rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: junguo bu, doctor
role: PRINCIPAL_INVESTIGATOR
References: