Esophageal cancer (EC) ranks the seventh most diagnosed malignant tumor (572,000 new cases) and the sixth cancer-related mortality (509,000 deaths) worldwide in 2018. The incidence of EC is strikingly varying among the regions and sexes. Approximately 70% of EC cases occur in men, and there is a 2-fold to 3-fold difference in incidence and mortality rates between regions worldwide. According to the latest reported in 2017, esophageal cancer ranks the sixth most common cancer and the fourth leading cause of cancer-mortality in China. Currently, esophagectomy is considered as the standard treatment for resectable EC patients. However, the prognosis of stage IIA-III esophageal cancer after esophagectomy remains poor, and local regional lymph node recurrence is the major patterns of recurrence, and mediastinal lymph node recurrence is one of the most common sites. Previous retrospective study has found that salvage chemoradiotherapy is a effective treatment option for these patients. However, the optimal dose remains unknown. In addition, no prospective trials have been conducted to investigate the efficacy and toxicities of salvage chemo-radiotherapy by using simultaneous integrated boost for the treatment of mediastinal lymph node recurrence after radical surgery of esophageal Cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Dose-escalation plan (phase I) Radiotherapy: LEVEL 1: dose given at PTV-G will be 58.8Gy/28 fractions； 2.1Gy/per fraction; LEVEL 2: dose given at PTV-G will be 64.4Gy/28 fractions； 2.3Gy/per fraction; LEVEL 3: dose given at PTV-G will be 70Gy/28 fractions； 2.5Gy/per fraction Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine
Radiotherapy dose was prescribed according to phase I trial results; Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGDose limiting toxicity(DLT) of Simulatianeous Integrated Boost (SIB)
DLT was defined as grade 4 or higher hematological toxicities and/or grade 3 or higher nonhematological toxicities.
Time frame: up to 3 months
Overall survival (phase II)
Survival time was measured from the date of study enrollment to the date of death or last follow-up;
Time frame: up to 1 year
Overall survival (phase I)
Survival time was measured from the date of study enrollment to the date of death or last follow-up;
Time frame: up to 1 year
Late toxicity (phase I)
late toxicity were grade according to RTOG and CTCAE criteria
Time frame: up to 2 year
Overall survival (phase II)
Survival time was measured from the date of study enrollment to the date of death or last follow-up;
Time frame: up to 2 year
acute Toxicity (phase II)
acute toxicity were grade according to CTCAE criteria
Time frame: up to 3 months
late Toxicity (phase II)
late toxicity were grade according to RTOG and CTCAE criteria
Time frame: up to 2 year
1-year local progression-free survival
From treatment initiation to first documented local progression or death or censor
Time frame: up to 1 year
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