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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Biotech Pharmaceutical Co., Ltd.
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01393184
First received: June 24, 2011
Last updated: July 12, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
SCCHN
 Drug: Nimotuzumab and Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Controlled, Phase II，Multiple Centered Clinical Trial of Nimotuzumab Combined With Radiotherapy for Senile Locally Advanced SCCHN

Further study details as provided by Peking University:

Primary Outcome Measures:
  • Objective response rate: complete response + partial response on RECIST evaluation system [ Time Frame: 1-month after treatment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: participants will be followed during the treatment,an expected average of 6 weeks ] [ Designated as safety issue: No ]
  • Objective response rate: complete response + partial response on RECIST [ Time Frame: 3-months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the Local control Rate in 2 years. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone. [ Time Frame: participants will be followed during the treatment,an expected average of 6 weeks ] [ Designated as safety issue: No ]
    Record the subjective description of the patients by themself according to the QOL table.

  • Evaluate the overall survival of the patient in 2 years. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Evaluate the progression free survival of the patient in 2 years. [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Evaluate the Quality of Life（QoL）of Senile Locally Advanced SCCHN treated by Nimotuzumab Combined with Radiotherapy or Radiotherapy alone. [ Time Frame: every 3 months after treatment ] [ Designated as safety issue: No ]
    Record the subjective description of the patients by themself according to the QOL table.

  • Evaluate the Local control Rate in 3 years. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Evaluate the Local control Rate in 5 years. [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Evaluate the overall survival of the patient in 3 years. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Evaluate the overall survival of the patient in 5 years. [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Evaluate the progression free survival of the patient in 3 years. [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • Evaluate the progression free survival of the patient in 5 years. [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 92
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy + Nimotuzumab
  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
Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT
Other Name: 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 Name: Nimotuzumab combined with radiotherapy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393184

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

No publications provided

Responsible Party: Peking University
ClinicalTrials.gov Identifier: NCT01393184     History of Changes
Other Study ID Numbers: BT-IST-SCCHN-040
Study First Received: June 24, 2011
Last Updated: July 12, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
Target therapy

ClinicalTrials.gov processed this record on May 22, 2013