Safety and Efficacy Study of Target Therapy Combined With Radiotherapy to Treat Senile Locally Advanced SCCHN

Prospective, Randomized, Controlled, Phase II，Multiple Centered Clinical Trial of Nimotuzumab Combined With Radiotherapy for Senile Locally Advanced SCCHN

Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence indicates combination with EGFR Target therapy can bring benefit for the patients. Senile Society is coming in China, the mean age in Beijing reaches 80 years old. A valuable treatment with efficacy and safety is needed for senile patient with SCCHN. The purpose of the study "Prospective, Randomized, Controlled, Phase II Multiple Centered Clinical Trial of Nimotuzumab Combined with Radiotherapy for Senile Locally Advanced SCCHN" was sponsored to evaluate the efficacy and safety for Nimotuzumab Combined with Radiotherapy in Senile SCCHN patients.

Study Overview

• Status: Unknown
• Conditions: SCCHN
• Intervention / Treatment: Drug: Nimotuzumab and Radiotherapy

Detailed Description

condition: Senile Locally Advanced SCCHN. Intervention: Drug:Nimotuzumab. Arm A: Radiotherapy+Nimotuzumab; Arm B: Radiotherapy alone. Phase: Phase 2

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent form
• Age 65-85，both genders
• HNSCC Confirmed by pathology
• Primary site of oral cavity, oropharynx, hypopharynx, larynx
• Stage Ⅲ/ⅣA,B
• Primary lesions can be measured
• Karnofsky's Performance Scale ≥60
• Life expectancy of more than 6 months
• Haemoglobin≥100g/L ,WBC ≥3.5×109/L, platelet count≥90×109/L
• Hepatic function: ALT、AST< 1.5 x ULN, TBIL< 1.5 x ULN
• Renal function: Creatinine < 1.5 x ULN

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy + Nimotuzumab; Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy & CTV 60 Gy/33F; Nimotuzumab (Nimo) weekly Nimo (200 mg) × 8, started 1 w before RT	Drug: Nimotuzumab and Radiotherapy; Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT; Other Names: Nimotuzumab combined with radiotherapy
Active Comparator: Radiotherapy (RT); Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy & CTV 60 Gy/33F	Drug: Nimotuzumab and Radiotherapy; Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT; Other Names: Nimotuzumab combined with radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate: complete response + partial response on RECIST evaluation system	1-month after treatment
Evaluate the Safety of Nimotuzumab Combined with Radiotherapy for old patients. Record the Number and Grade of Participants with Adverse Events as a Measure of Safety and Tolerability	participants will be followed during the treatment,an expected average of 6 weeks
Objective response rate: complete response + partial response on RECIST	3-months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Local control Rate in 2 years.		up to 2 years
Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone.	Record the subjective description of the patients by themself according to the QOL table.	participants will be followed during the treatment,an expected average of 6 weeks
Evaluate the overall survival of the patient in 2 years.		up to 2 years
Evaluate the progression free survival of the patient in 2 years.		up to 2 years
Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone.	Record the subjective description of the patients by themself according to the QOL table.	every 3 months after treatment
Evaluate the Local control Rate in 3 years.		up to 3 years
Evaluate the Local control Rate in 5 years.		up to 5 years
Evaluate the overall survival of the patient in 3 years.		up to 3 years
Evaluate the overall survival of the patient in 5 years.		up to 5 years
Evaluate the progression free survival of the patient in 3 years.		up to 3 years
Evaluate the progression free survival of the patient in 5 years.		up to 5 years

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: Biotech Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Sun Yan, MD, Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: June 24, 2011
• First Submitted That Met QC Criteria: July 12, 2011
• First Posted (Estimate): July 13, 2011

Study Record Updates

• Last Update Posted (Estimate): July 13, 2011
• Last Update Submitted That Met QC Criteria: July 12, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Target therapy
• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: BT-IST-SCCHN-040