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


Phase 2
65 Years
85 Years
Open (Enrolling by invite only)
Both
SCCHN

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective response rate: complete response + partial response on RECIST evaluation system

Outcome Time Frame:

1-month after treatment

Safety Issue:

No

Principal Investigator

Sun Yan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

China: Food and Drug Administration

Study ID:

BT-IST-SCCHN-040

NCT ID:

NCT01393184

Start Date:

March 2011

Completion Date:

March 2013

Related Keywords:

  • SCCHN
  • Target therapy

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