Status:
COMPLETED
A Multicenter Trial Comparing Induction C/T Followed by CCRT v.s. CCRT Alone in Stage IV Nasopharyngeal Carcinoma
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Tri-Service General Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE3
Brief Summary
Investigate the effect of induction MEPFL chemotherapy followed by concurrent chemoradiotherapy (CCRT) on the disease control and survival in treatment of patients with advanced NPC.
Detailed Description
Rationale of induction chemotherapy: Distant metastasis is the major cause of treatment failure and deaths in patients with loco-regionally advanced NPC. Concurrent chemoradiotherapy may prolong sur...
Eligibility Criteria
Inclusion
- Histologically proved nasopharyngeal carcinoma.
- T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30)
- Eastern Cooperative Oncology Group performance status \< 2.
- A leukocyte count ≥3750/mL, Hb ≥ 10 g/dL, and a platelet count ≥100,000/mL.
- A serum bilirubin level \< 1.5 mg/dL, serum creatinine level \< 1.6 mg/dL or creatinine clearance \> 60 mL/min.
- Age less than 70 years old
- An informed consent signed.
Exclusion
- Evidence of metastatic disease.
- Presence of another malignancy other than treated squamous/basal cell carcinoma of the skin.
- Presence of uncontrolled hypertension, poorly controlled heart failure.
- Presence of active infection.
- Patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies.
- Women who test positive for pregnancy.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00201396
Start Date
August 1 2003
End Date
December 1 2011
Last Update
February 25 2015
Active Locations (4)
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1
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 80708
2
China Medical University Hospital
Taichung, Taiwan, 40447
3
National Taiwan University Hospital
Taipei, Taiwan, 115
4
Chang-Gung Memorial Hospital(Lin-Kou),
Taoyuan District, Taiwan, 333