Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx
1 other identifier
interventional
80
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2012
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedMarch 20, 2012
March 1, 2012
1.5 years
January 11, 2012
March 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Objective response rate
Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
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.
Participants will be followed during the treatment and 3 months after all the treatment ending ,an expected average of 26 weeks
Secondary Outcomes (5)
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
Evaluate the Local control Rate in 1 to 5 years.
Participants will be followed every year for the duration of 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
Study Arms (2)
Neoadjuvant and CCRT
ACTIVE COMPARATORNeoadjuvant and CCRT and Nimotuzumab
EXPERIMENTALInterventions
* 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
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
Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13\~14 weeks
Eligibility Criteria
You may qualify if:
- 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；
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Gansu Province Medical Science Institute
Lanzhou, Gansu, 730050, China
Guangxi Tumor Hospital
Nanning, Guangxi, 530021, China
GuiZhou Cancer Hospital
Guiyang, Guizhou, 550004, China
Neimenggu Tumor Hospital
Baotou, Neimenggu, 014030, China
The Tumor Affiliated Hospital of Ningxia Medical University General Hospita
Yinchuan, Ningxia, 750004, China
Qinghai Five Hospital
Xining, Qinghai, China
ShanXi Cancer Hospital
Xian, Shanxi, 710061, China
Xijing Hospital
Xi’an, Shanxi, 710032, China
The Second People's Hospital of Sichuan
Chengdu, Sichuan, 610041, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Sichuan, 400042, China
Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University
Kunming, Yunnan, 652100, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi J Lang, M.D.
Radiotherapy department
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of radiotherapy department
Study Record Dates
First Submitted
January 11, 2012
First Posted
January 25, 2012
Study Start
March 1, 2012
Primary Completion
September 1, 2013
Study Completion
March 1, 2018
Last Updated
March 20, 2012
Record last verified: 2012-03