The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma.
The most optimal management for postoperative locoregional recurrence of oesophageal squamous cell carcinoma is still controversial. Several studies have reported the feasibility and efficacy of concurrent chemoradiotherapy (CCRT), mostly with three-weekly or four-weekly schedule of chemotherapy. However, treatment compliance was not quite satisfactory, probably due to treatment-related toxicities. Since CCRT with weekly chemotherapy regimens have demonstrated a favorable toxicity profile as well as promising survival in certain types of cancer, the investigators aimed to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy with 5-fluorouracil (5-FU) and cisplatin for patients with postoperative locoregional recurrence of oesophageal squamous cell carcinoma in the investigators center.The prescribed dose of radiotherapy is generally 60Gy/28fr to tumor and 50Gy/28fr to the clinical target volume.The concomitant chemotherapy is cisplatin 25mg/m2 on day 1, 5-FU 1176mg/m2 on day 1-3, repeated weekly for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
SYSU Cancer Center
Guangzhou, Guangdong, China
RECRUITINGoverall response rate
RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine the tumor response. Tumor response was evaluated by CT 8 weeks after chemoradiotherapy.
Time frame: within 8 weeks after the treatment(plus or minus 5 days)
safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).
A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up
Time frame: up to 3 years
overall survival
A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up
Time frame: up to 3 years
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