This study examines contrast advantages and disadvantages of elective or prophylactic nodal irradiation in the treatment of esophageal cancer with three-dimensional conformed radiotherapy.
Esophageal lymph node drainage area is rich, according to different sites, easy to metastasis to different regions. For patient underwent concurrent chemoradiotherapy, how reasonable design the clinical target volume of lymph node drainage area has always been controversial, one is to irradiate positive lymph nodes only, the other is to irradiate the easier involved lymph node area according to different sites, in order to contrast advantages and disadvantages of the two kind of target area design,so the study was designed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Involved Field Irradiation(IFI):only irradiate positive lymph node by CT or PET-CT Radiation: IMRT IMRT is administered with chemotherapy from week 1 to week 8PTV-GTV(primary tumor):66-70Gy/33\~35F,once a day, 5 times per week PTV-CTV(Clinical target,primary tumor extended 3cm in Axial):50-56Gy/33\~35f,once a day, 5 times per week PTV-GTVnd(positive node):66-70Gy/33\~35F,once a day, 5 times per week.
Drug: docetaxel and cisplatin.Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.
The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.
Guangxi Tumor Hospital
Nanning, Guangxi, China
GuiZhou Cancer Hospital
Guiyang, Guizhou, China
The Second People's Hospital of Sichuan
Chengdu, Sichuan, China
Yunnan Tumor Hospital, The Third Affiliated Hospital of KUNMING Medical University
Kunming, Yunnan, China
radiation pneumonitis and radiation esophagitis
radiation pneumonitis and radiation esophagitis,
Time frame: Acute and late toxicities of lung and esophagus were evaluated according to RTOG criteria with CT scans every 3 months for 1 years
3-year Overall survival(OS)
3-year Overall survival(OS)
Time frame: CT scans performed every 6 months for 3 years
3-year Disease-free survival
3-year Disease-free survival
Time frame: CT scans every 6 months for 3 years
Quality of life(QoL)
Quality of life(QoL)
Time frame: Evaluation of quality of life every week for 3 months
Local control rate/ Inside irrational field recurrence rate
Evaluation after treatment 3 months and two years in the tumor local control and key observation radiation fields inside and outside the tumor recurrence and lymph node metastatic rate. To guide the rational clinical target volume of lymph node of esophageal cancer underwnet concurrent chemoradiotherapy and to Prolong the survival time, improve the quality of life of the patients.
Time frame: 2 year
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