Clinical trial NCT01516996: Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
Official title: Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oropharyngeal Cancer
Hypopharyngeal Cancer
Keywords: Neoadjuvant
Concurrent Chemoradiotherapy,CCRT
Nimotuzumab
Locoregionally Advanced Oropharynx
Hypopharynx cancer
Randomized
Multicenter
Lead sponsor: The Second People's Hospital of Sichuan
Sponsor class: OTHER
Collaborators: name: Biotech Pharmaceutical Co., Ltd.
First posted: 2012-01-25
Enrollment: 80
Sex: ALL
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 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: 3 months after all the treatment ending
measure: The Number of Participants with Adverse Events
timeFrame: Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of randomization until the date of death from any cause,assessed up to 5 years
measure: Progression-Free Survival
timeFrame: 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
measure: Evaluate the Local control Rate in 1 to 5 years.
timeFrame: Participants will be followed every year for the duration of 5 years
measure: Tumor-Free Survival
timeFrame: From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years
measure: Non-metastatic Rate
timeFrame: The time from randomization until distant relapse occur,assessed up to 5 years
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Gansu Province Medical Science Institute
state: Gansu
city: Nanning
country: China
facility: Guangxi Tumor Hospital
state: Guangxi
city: Guiyang
country: China
facility: GuiZhou Cancer Hospital
state: Guizhou
city: Baotou
country: China
facility: Neimenggu Tumor Hospital
state: Neimenggu
city: Yinchuan
country: China
facility: The Tumor Affiliated Hospital of Ningxia Medical University General Hospita
state: Ningxia
city: Xining
country: China
facility: Qinghai Five Hospital
state: Qinghai
city: Xi-an
country: China
facility: Xijing Hospital
state: Shanxi
city: Xian
country: China
facility: ShanXi Cancer Hospital
state: Shanxi
city: Chengdu
country: China
facility: The Second People's Hospital of Sichuan
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Sichuan
city: Wulumuqi
country: China
facility: Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University
state: Yunnan
Study officials:
affiliation: Radiotherapy department
name: Yi J Lang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: