The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma.
108 patients were randomized to receive no induction chemotherapy (IC, Arm A) or IC (Arm B) before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma. Patients assigned to Arm B first received two cycles of 3-weekly schedule of IC, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
definitive radiotherapy
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
overall response rate (clinical complete response and partial response)
RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response. Tumor response was evaluated 3 months after the completion of treatment based on barium esophagography, CT scans, and endoscopy with biopsies.
Time frame: 3 months after chemoradiotherapy (plus or minus 7 days)
Overall survival
Three years follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Time frame: 3 years
Progression-free survival
From the date of randomization to the date of disease progression or last follow-up
Time frame: 3 years
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