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Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Nasopharyngeal Carcinoma

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Trial Information

Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)

Inclusion Criteria


Inclusion criteria:

- Recurrent T3N0-N1M0 NPC (by AJCC/UICC 6th edition) and at least 1 year from the end
of last primary course of radiotherapy

- Age > 18 to < 70 years

- Performance status: < 1 by ECOG System (Appendix I)

- Adequate bone marrow & renal function

- Patients having Bilirubin =< 1.5 x ULN, ASAT & ALST=< 1.5 x ULN, Serum creatinine=<
1.25 x ULN and / or Creatinine clearance >= 60ml/min

- Patients having WBC >= 3x10e9/L, Neutrophils 1.8x10e9/L, Platelets >= 100
x10e9/L,Hemoglobin >=10g/dL

- Signed written informed consent

- Patients must have at least one measurable lesion

Exclusion Criteria:

- Use of investigational agent within the past 28 days

- Pre-treatment with an anti-EGFR drug

- Severe cardiac disease such as heart failure, coronary artery disease or myocardial
infarction within the last 12 months

- History of severe pulmonary diseases

- Active infection or other systemic disease under poor control

- Uncontrolled chronic neuropathy

- Know grade 3 or 4 allergic reaction to any of the components of the treatment

- Estimated life expectancy is less than 3 months

- Pregnancy or breast feeding

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete response rate

Outcome Description:

Complete response rate is defined as the proportion of subjects with disappearance of all target lesions after induction and concurrent therapies.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Lee Anne W.M., F.R.C.R.(HK)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong

Authority:

Hong Kong: Department of Health

Study ID:

NPC-1001 trial

NCT ID:

NCT01326559

Start Date:

June 2010

Completion Date:

December 2013

Related Keywords:

  • Nasopharyngeal Carcinoma
  • induction chemotherapy
  • docetaxel
  • cisplatin
  • fluorouracil
  • cetuximab
  • intensity-modulated radiotherapy
  • Carcinoma
  • Nasopharyngeal Neoplasms

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