The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China
RECRUITINGOverall survival (OS)
Time frame: 1 year
Overall survival (OS)
Time frame: 2 year
Overall survival (OS)
Time frame: 3 year
Progression-free survival (PFS)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 2 year
Progression-free survival (PFS)
Time frame: 3 year
Local recurrence-free rate(LRFS)
Time frame: 1 year
Local recurrence-free rate(LRFS)
Time frame: 2 year
Local recurrence-free rate(LRFS)
Time frame: 3 year
Completion Rate
Time frame: up to 2 year
Adverse events
Time frame: up to 5 year
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135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.