Know Cancer

forgot password

Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma

Phase 2
18 Years
69 Years
Not Enrolling
Nasopharyngeal Carcinoma

Thank you

Trial Information

Phase II Study of Cetuximab Combined With Intensity Modulated Radiotherapy (IMRT) and Concurrent Chemotherapy of Cisplatin in Nasopharyngeal Carcinoma

Inclusion Criteria:

- Informed consent form signed prior to study entry

- Age between 18-69 years old

- Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)

- Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th
edition criteria

- Primary tumor measurable

- KPS score ≥80

- Expected life span ≥6 months

- Adequate bone marrow function: White Blood

- Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (ULN), bilirubin

- Adequate renal function: Creatinine Clearance < 1.5×ULN

Exclusion Criteria:

- Evidence of distant metastatic disease

- Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)

- Previous radiotherapy for the primary tumor or lymph nodes

- Previous exposure to epidermal growth factor-targeted therapy

- Prior chemotherapy or immunotherapy for the primary tumor

- Other previous malignancy within 5 years, except non-melanoma skin cancer or
pre-invasive carcinoma of the cervix

- Any investigational agent prior to the 1st study medication

- Participation in another clinical study within the 30 days prior to Inclusion in this

- Peripheral neuropathy > grade 1

- Known grade 3 or 4 allergic reaction to any of the study treatment

- History of severe pulmonary or cardiac disease

- Creatinine Clearance < 30ml/min

- Know drug abuse / alcohol abuse

- Legal incapacity or limited legal capacity

- Active systemic infection

- Medical or psychiatric illness, which in the investigators' opinions, would not
permit the subject to complete or fully and completely understand the risks and
potential complications of the study

- Concurrent chronic systemic immune therapy or hormone therapy not indicated in the
study protocol

- Pregnancy (confirmed by serum or urine β-HCG) or lactation period

- Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy

Outcome Description:

The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Tai-xiang Lu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Departments of Radiation Oncology, Cancer Center, Sun Yat-sen University


China: Ethics Committee

Study ID:




Start Date:

July 2008

Completion Date:

April 2009

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Radiotherapy
  • chemotherapy
  • Drug Targeting
  • loco-regionally advanced nasopharyngeal carcinoma
  • Safety.
  • efficacy
  • Carcinoma
  • Nasopharyngeal Neoplasms