Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

The Second People's Hospital of Sichuan80 enrolled

Overview

The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oropharyngeal Cancer Hypopharyngeal Cancer

Interventions

docetaxel and cisplatinDRUG

* The neoadjuvant consists of docetaxel 75mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles. * CCRT: cisplatin 75mg/m2 is administered on day 1 of week 7,10 and 13 on current with RT

IMRTRADIATION

IMRT is administered with chemotherapy from week 7 to week 13 * GTV（primary tumor）：68-70Gy/35\~38 F，once a day, 5 times per week * CTV（Clinical target）：56-66Gy/30\~36f，once a day, 5 times per week * GTV-ln（positive neck region）：66-70Gy/33\~36 F，once a day, 5 times per week * CTV-ln（negative neck region）：50-54Gy/28\~30F, once a day, 5 times

NimotuzumabBIOLOGICAL

Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\~14 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent form * Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx * The tumor mass had to be measurable * Karnofsky performance status ≥70 * Life expectancy estimated than 6 months * Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L； * Hepatic: AST/ALT\<1.5 times upper limit of normal (ULN)；serum bilirubin\<1.5 times ULN; * Renal: Creatinine\<1.5 times ULN； Exclusion Criteria: * Known distant metastases * Primary tumor and nodes received surgery(except of biopsy) * Received other anti EGFR monoclonal antibody treatment * Previous chemotherapy or radiotherapy * Participation in other interventional clinical trials within 1 month * Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix) * History of serious allergic or allergy * History of Serious lung or heart disease * Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant

Locations (13)

Gansu Province Medical Science Institute

Lanzhou, Gansu, China

ACTIVE_NOT_RECRUITING

Guangxi Tumor Hospital

Nanning, Guangxi, China

Outcomes

Primary Outcomes

Objective response rate

Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.

Time frame: 3 months after all the treatment ending

The Number of Participants with Adverse Events

Record the Number of participants with adverse events and the Grades of the AE according to CTCAE v3.0 as the two measure of safety.

Time frame: Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks

Secondary Outcomes

Overall Survival

Time frame: From date of randomization until the date of death from any cause,assessed up to 5 years

Progression-Free Survival

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Evaluate the Local control Rate in 1 to 5 years.

To evaluate each year until 5 years later

Time frame: Participants will be followed every year for the duration of 5 years

Tumor-Free Survival

Time frame: From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years

Non-metastatic Rate

Time frame: The time from randomization until distant relapse occur,assessed up to 5 years

Data from ClinicalTrials.gov

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