Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
- Conditions
- Oropharyngeal CancerHypopharyngeal Cancer
- Interventions
- Registration Number
- NCT01516996
- Lead Sponsor
- The Second People's Hospital of Sichuan
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
- 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；
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neoadjuvant and CCRT and Nimotuzumab docetaxel and cisplatin - Neoadjuvant and CCRT docetaxel and cisplatin - Neoadjuvant and CCRT IMRT - Neoadjuvant and CCRT and Nimotuzumab IMRT - Neoadjuvant and CCRT and Nimotuzumab Nimotuzumab -
- Primary Outcome Measures
Name Time Method Objective response rate 3 months after all the treatment ending Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
The Number of Participants with Adverse Events Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks 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.
- Secondary Outcome Measures
Name Time Method Evaluate the Local control Rate in 1 to 5 years. Participants will be followed every year for the duration of 5 years To evaluate each year until 5 years later
Overall Survival From date of randomization until the date of death from any cause,assessed up to 5 years Progression-Free Survival 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 Tumor-Free Survival From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years Non-metastatic Rate The time from randomization until distant relapse occur,assessed up to 5 years
Trial Locations
- Locations (13)
Qinghai Five Hospital
🇨🇳Xining, Qinghai, China
Xijing Hospital
🇨🇳Xi-an, Shanxi, China
The Tumor Affiliated Hospital of Ningxia Medical University General Hospita
🇨🇳Yinchuan, Ningxia, China
The Second People's Hospital of Sichuan
🇨🇳Chengdu, Sichuan, China
ShanXi Cancer Hospital
🇨🇳Xian, Shanxi, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
🇨🇳Chongqing, Sichuan, China
Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University
🇨🇳Wulumuqi, Xinjiang, China
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University
🇨🇳Kunming, Yunnan, China
Gansu Province Medical Science Institute
🇨🇳Lanzhou, Gansu, China
Guangxi Tumor Hospital
🇨🇳Nanning, Guangxi, China
GuiZhou Cancer Hospital
🇨🇳Guiyang, Guizhou, China
Neimenggu Tumor Hospital
🇨🇳Baotou, Neimenggu, China