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

SCCHN Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01393184
• Other study ID #: BT-IST-SCCHN-040
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: June 24, 2011
• Last updated: July 12, 2011
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2011
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 92
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Informed consent form

• Age 65-85,both genders

• HNSCC Confirmed by pathology

• Primary site of oral cavity, oropharynx, hypopharynx, larynx

• Stage ?/?A,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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• SCCHN

Intervention

Drug:
• Nimotuzumab and Radiotherapy
Nimotuzumab (Nimo): Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Biotech Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate: complete response + partial response on RECIST evaluation system		1-month after treatment	No
Primary	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	No
Primary	Objective response rate: complete response + partial response on RECIST		3-months after treatment	No
Secondary	Evaluate the Local control Rate in 2 years.		up to 2 years	No
Secondary	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	No
Secondary	Evaluate the overall survival of the patient in 2 years.		up to 2 years	No
Secondary	Evaluate the progression free survival of the patient in 2 years.		up to 2 years	No
Secondary	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	No
Secondary	Evaluate the Local control Rate in 3 years.		up to 3 years	No
Secondary	Evaluate the Local control Rate in 5 years.		up to 5 years	No
Secondary	Evaluate the overall survival of the patient in 3 years.		up to 3 years	No
Secondary	Evaluate the overall survival of the patient in 5 years.		up to 5 years	No
Secondary	Evaluate the progression free survival of the patient in 3 years.		up to 3 years	No
Secondary	Evaluate the progression free survival of the patient in 5 years.		up to 5 years	No