Concomitant radiotherapy and weekly cisplatin with or without prior induction chemotherapy with cisplatin, epirubicin and paclitaxel (CEP) in patients with locally advanced nasopharyngeal carcinoma
- Conditions
- ocally advanced nasopharyngeal carcinomaLocally advanced nasopharyngeal carcinomaCancer - Head and neck
- Registration Number
- ACTRN12609000730202
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 148
Disease characteristics:
1.Biopsy - proven, previously untreated, World Health Organisation (WHO) type I, II or undifferentiated NPC.
2.Stage IIB-IVB [Union Internationale Contre le Cancer (UICC) and the American Joint Committee on Cancer (AJCC)] after pre-therapeutic extensive workup 3.Measurable or evaluable disease required.
3. No synchronous primary tumors.
4. Chest x-ray, bone scan and liver imaging prior to initiation of treatment.
5. Computed tomography (CT) scan and/or Magnetic Resonance Imaging (MRI) of the head and neck region prior to initiation of treatment.
Patient characteristics:
1. Age: 15 years and over.
2. Performance status: WHO 0 - 2
3. Hematopoietic: White Blood Cells (WBC) > 3,500 and platelets >100,000.
4. Renal: creatinine clearance >50 ml/min (measured or calculated) and serum calcium normal.
5. Hepatic: Alkaline phosphatase (ALP) and Serum glutamic oxaloacetic transaminase (SGOT) normal.
6.Cardiovascular: status adequate to tolerate all protocol treatment.
7.Pulmonary: status adequate to tolerate all protocol treatment.
8.Nutritional status: status adequate to tolerate all protocol treatment.
9.Mental status: adequate to follow instructions, keep appointments and provide written informed consent prior to study entry.
10.Life expectancy of at least 3 months.
Prior therapy:
No prior biologic, chemotherapy, surgery or radiotherapy to the head and neck is allowed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR). The ORR will be assessed by imaging methods including computed tomography (CT) scan and magnetic resonance imaging (MRI) of the head and neck region[2-3 months after the completion of chemoradiotherapy]
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS)[Patients will be followed-up for 3 years after entering the study];Overall survival (OS)[Patients will be followed-up for 3 years after entering the study];acute toxicity[6 months after study completion. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc.];We will also conduct translational research studies to assess tumor samples for predictive biomarkers.[Research studies will commence following collection of tumour samples for up to 5 years following completion of this study]