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Completed

NCT Number: NCT00700440

Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy

This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Cell≥4×109/L,Hemoglobin≥100g/L,Platelet≥100×109/L
  • Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (ULN), bilirubin <1.5×ULN
  • 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 study.
  • 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

Treatment and study plan

C225 (cetuximab)

Drug

one week before and then weekly during radiotherapy

Other names: Erbitux

Primary outcomes

  1. 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy

    Time frame: 3 months

    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.

Secondary outcomes

  1. 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Cancer Hospital of Guizhou Province
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Central South University
  • First Affiliated Hospital of Guangxi Medical University
  • Fudan University
  • Fujian Cancer Hospital
  • Sichuan Cancer Hospital and Research Institute

Registry information

Official study title

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

Acronym: ENCORE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 18, 2008
Registry last updated
Mar 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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