A Multicenter Phase III Trial Comparing Induction Chemotherapy Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Alone in Stage IV Nasopharyngeal Carcinoma (NPC)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 480
- Locations
- 4
- Primary Endpoint
- The primary endpoint is the disease-free survival.
Study Overview
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 survivals for patients with advanced NPC, but it is still flawed by high incidence of distant metastasis.
Induction chemotherapy with MEPFL has been shown to reduce the incidence of distant metastasis in a Phase II study.
Induction chemotherapy plus concurrent chemoradiotherapy may improve the survival of patients with advanced NPC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically proved nasopharyngeal carcinoma.
- •T4NxM0 or TxN3M0 disease by UICC/AJCC 1997 staging system. (30)
- •Eastern Cooperative Oncology Group performance status <
- •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 Criteria
- •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.
Arms & Interventions
A arm
CCRT
Intervention: CCRT (Radiation)
B arm
Induction/CCRT
Intervention: CCRT (Radiation)
B arm
Induction/CCRT
Intervention: Mitomycin C,Epirubicin,Cisplatin,5-Fluorouracil,Leucovorin (Drug)
Outcomes
Primary Outcomes
The primary endpoint is the disease-free survival.
Time Frame: 10 years
follow up for 2 years after off study treatment
Secondary Outcomes
- Secondary endpoints include overall survival and tumor response rate.(10 years)