The objectives of this clinical study are threefold: 1. To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation. 2. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay. 3. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
1. primary objectives include 1. comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF) 2. comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF) 3. comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy. 2. secondary objectives include 1. comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P) 2. Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
803
Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles
Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles
Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles
Cancer Center, Sun Yat Sen University
Guangzhou, China
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, China
Department of Clinical Oncology, Princess Margaret Hospital
Hong Kong, China
Department of Clinical Oncology, Queen Elizabeth Hospital
Hong Kong, China
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong, China
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong, China
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
Time frame: 5 years
Overall Survival, defined as the time to death due to any cause, at 5-year.
Time frame: 5 years
overall Failure-Free Rate, defined as time to failure at any site)
Time frame: 5 years
Loco-regional Failure-Free Rate, defined as time to local or nodal failure)
Time frame: 5 years
Distant Failure-Free Rate, defined as time to distant failure)
Time frame: 5 years
Incidence of chemotherapy toxicity and acute RT toxicity grade > 3
Time frame: treatment
Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.