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

NCT01393184 | Unknown Phase 2 DMC

• 1 other identifier: BT-IST-SCCHN-040
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

SCCHN

Keywords

Target therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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.

  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.

  every 3 months after treatment

Study Arms (2)

Radiotherapy + Nimotuzumab

EXPERIMENTAL

1. Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy \& CTV 60 Gy/33F 2. Nimotuzumab (Nimo) weekly Nimo (200 mg) × 8, started 1 w before RT

Drug: Nimotuzumab and Radiotherapy

Radiotherapy (RT)

ACTIVE COMPARATOR

Radiotherapy (RT) Technique: IMRT, Rapid Arc, Tomotherapy Total dose: GTV 70 Gy \& CTV 60 Gy/33F

Drug: Nimotuzumab and Radiotherapy

Interventions

Nimotuzumab and Radiotherapy DRUG

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

Also known as: Nimotuzumab combined with radiotherapy

Radiotherapy (RT); Radiotherapy + Nimotuzumab

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University: lead
• Biotech Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Interventions

nimotuzumab; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sun Yan, MD

  Peking University, School of Oncology, Beijing Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: July 13, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 13, 2011

Record last verified: 2011-03