A Randomised Phase ll/Lll Study of Concurrent Cisplatin-Radiotherapy With or Without Induction Chemotherapy Using Gemcitabine, Carboplatin and Paclitaxel in Locally Advanced Nasopharyngeal Cancer
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Randomised Phase ll/Lll Study of Concurrent Cisplatin-Radiotherapy With or Without Induction Chemotherapy Using Gemcitabine, Carboplatin and Paclitaxel in Locally Advanced Nasopharyngeal Cancer
OBJECTIVES:
Primary
- To compare the 5-year overall survival of patients with locally advanced nasopharyngeal
cancer treated with concurrent cisplatin and radiotherapy with vs without induction
chemotherapy comprising gemcitabine hydrochloride, carboplatin, and paclitaxel.
Secondary
- To assess and compare the disease-free survival, distant metastases rate, toxicities,
and quality of life of patients treated with these regimens.
OUTLINE: Patients are stratified by N-stage (N0-1 vs N2-3) and are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive cisplatin IV over 2 hours once weekly on weeks 1-8 and undergo
intensity-modulated radiotherapy once daily, 5 days a week, on weeks 1-7 (6½ weeks for
a total of 33 fractions).
- Arm II: Patients receive induction chemotherapy comprising gemcitabine hydrochloride IV
over 30 minutes, carboplatin IV over 1 hour, and paclitaxel IV over 1 hour on days 1
and 8. Treatment repeats every 21 days for 3 courses. Beginning at least 3 weeks after
the last dose of induction chemotherapy, patients receive cisplatin and undergo
radiotherapy as in arm I.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed every 2 months for 1 year, every
4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed nasopharyngeal cancer
- Loco-regionally advanced disease (International Union Against Cancer [IUCC]
stage III or IV [T3-4, any N or any T, N2-3])
- WHO type II or III disease
- No evidence of metastatic disease in staging work up (including lung, liver, and
bone imaging)
- Must have undergone cross-sectional imaging of the primary and neck disease (MRI)
- Evaluable disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC > 3,000/mm^3
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin > 10 g/dL
- Serum creatinine normal
- Creatinine clearance > 50 mL/min
- Serum alkaline phosphatase < 2 times normal
- SGOT < 2 times normal
- Total bilirubin < 24 μmol/L
- No uncontrolled hypercalcemia (calcium ≥ 2.7 mmol/L [10.8 mg/dL])
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraceptives
- No second primary malignancy except for in situ carcinoma of the cervix or adequately
treated basal cell carcinoma of the skin
- No serious active infection
- Not a hepatitis B carrier
- No other serious concurrent systemic disorders deemed incompatible with the study by
the investigator
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment including chemotherapy or radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival at 5 years
Safety Issue:
No
Principal Investigator
Terence Tan, FRCR
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Centre, Singapore
Authority:
Unspecified
Study ID:
CDR0000657121
NCT ID:
NCT00997906
Start Date:
September 2009
Completion Date:
Related Keywords:
- Head and Neck Cancer
- stage III lymphoepithelioma of the nasopharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- Head and Neck Neoplasms
- Nasopharyngeal Neoplasms
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