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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Peking University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01393184
First Posted: July 13, 2011
Last Update Posted: July 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biotech Pharmaceutical Co., Ltd.
Information provided by:
Peking University
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • 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 ]
  • Objective response rate: complete response + partial response on RECIST [ Time Frame: 3-months after treatment ]

Secondary Outcome Measures:
  • Evaluate the Local control Rate in 2 years. [ Time Frame: up to 2 years ]
  • 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 ]
    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 ]
  • Evaluate the progression free survival of the patient in 2 years. [ Time Frame: up to 2 years ]
  • 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 ]
    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 ]
  • Evaluate the Local control Rate in 5 years. [ Time Frame: up to 5 years ]
  • Evaluate the overall survival of the patient in 3 years. [ Time Frame: up to 3 years ]
  • Evaluate the overall survival of the patient in 5 years. [ Time Frame: up to 5 years ]
  • Evaluate the progression free survival of the patient in 3 years. [ Time Frame: up to 3 years ]
  • Evaluate the progression free survival of the patient in 5 years. [ Time Frame: up to 5 years ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Peking University
ClinicalTrials.gov Identifier: NCT01393184     History of Changes
Other Study ID Numbers: BT-IST-SCCHN-040
First Submitted: June 24, 2011
First Posted: July 13, 2011
Last Update Posted: July 13, 2011
Last Verified: March 2011

Keywords provided by Peking University:
Target therapy