None listed
Conditions
Brief summary
The aim of this phase II randomized study was to compare the overall response rate (ORR), the progression-free survival (PFS), the overall survival (OS) and the acute toxicity of previously untreated patients with locally advanced non-nasopharyngeal carcinoma (LA-NPC).Patients were randomized to either 3 cycles of IC with cisplatin 75mg/m2, epirubicin 75mg/m2 and paclitaxel 175mg/m2 (CEP) every 3 weeks followed by definitive radiotherapy 70 Gy and concomitant weekly cisplatin 40mg/m2 (CCRT) or CCRT alone.
Interventions
Epirubicin 75 mg/m2 in 20 min infusion followed by paclitaxel 175 mg/m2 in 3-hr infusion, preceded by standard premeditation, on day 1 and cisplatin 75 mg/m2 in 2-hr infusion on day 2. Each cycle will be repeated every 3 weeks.
Cisplatin prehydration
2 liters of glucose 5% solution intravenous (IV) + 6 g of Sodium Chloride (NaCL)/l IV + 2 g Potassium Chloride(KCL)/l IV to be infused in 3 hours.
Mannitol 10% solution 250 ml in 1/2 hour before cisplatin; cisplatin 100 mg/m2 in 125 ml normal sali
Epirubicin 75 mg/m2 in 20 min infusion followed by paclitaxel 175 mg/m2 in 3-hr infusion, preceded by standard premeditation, on day 1 and cisplatin 75 mg/m2 in 2-hr infusion on day 2. Each cycle will be repeated every 3 weeks. Cisplatin prehydration 2 liters of glucose 5% solution intravenous (IV) + 6 g of Sodium Chloride (NaCL)/l IV + 2 g Potassium Chloride(KCL)/l IV to be infused in 3 hours. Mannitol 10% solution 250 ml in 1/2 hour before cisplatin; cisplatin 100 mg/m2 in 125 ml normal saline + 250 ml of mannitol in 1 hour. Cisplatin posthydration 2 liters of glucose 5% solution + 6 g NaCl/l and 2 g KCl/l. 1 vial/l of magnesium sulphate, in 3 hours. Cisplatin 40 mg/m2 in 1 hour infusion weekly x 7, 1 h prior to radiotherapy (RT) will be administered during the RT period.
Sponsors
Hellenic Cooperative Oncology Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Prior therapy: No prior biologic, chemotherapy, surgery or radiotherapy to the head and neck is allowed.
Outcome results
None listed