So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question. Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
Different radiotherapy dose in different groups.
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
RECRUITINGHuadong Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGFudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGoverall survival difference of definitive radiotherapy and chemoradiotherapy groups
The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
Time frame: 3-year
difference of quality of life between different groups
Assess the quality of life through life quality questionnaire.
Time frame: the period of treatment within 7 weeks and follow up time with an average of 3months
radiation side effects
Record the radiation side effects including acute and late side effects.
Time frame: acute side effects within 3 months, late side effects for 3 months later
cancer specific survival
The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study.
Time frame: 3-year
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