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

Oropharyngeal Cancer Clinical Trial

Official title:

Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01516996
• Other study ID #: BT-IST-SCCHN-036
• Status: Recruiting
• Phase: Phase 2
• First received: January 11, 2012
• Last updated: March 18, 2012
• Start date: March 2012
• Est. completion date: March 2018

Study information

• Verified date: March 2012
• Source: The Second People's Hospital of Sichuan
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2018
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypopharyngeal Cancer
• Hypopharyngeal Neoplasms
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Drug:
• docetaxel and cisplatin
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

Radiation:
• IMRT
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

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

Locations

Country	Name	City	State
China	Neimenggu Tumor Hospital	Baotou	Neimenggu
China	The Second People's Hospital of Sichuan	Chengdu	Sichuan
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	GuiZhou Cancer Hospital	Guiyang	Guizhou
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	Xinjiang tumor hospital, The Third Affiliated Hospital of Xinjiang Medical University	Wulumuqi	Xinjiang
China	Xijing Hospital	Xi-an	Shanxi
China	ShanXi Cancer Hospital	Xian	Shanxi
China	Qinghai Five Hospital	Xining	Qinghai
China	The Tumor Affiliated Hospital of Ningxia Medical University General Hospita	Yinchuan	Ningxia

Sponsors (2)

Lead Sponsor	Collaborator
The Second People's Hospital of Sichuan	Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Overall Survival		From date of randomization until the date of death from any cause,assessed up to 5 years	No
Secondary	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	No
Secondary	Evaluate the Local control Rate in 1 to 5 years.	To evaluate each year until 5 years later	Participants will be followed every year for the duration of 5 years	No
Secondary	Tumor-Free Survival		From date of randomization until the date of first documented occurrence of primary, neck, distant relapse,assessed up to 5 years	No
Secondary	Non-metastatic Rate		The time from randomization until distant relapse occur,assessed up to 5 years	No