Chemoselection as a strategy for organ preservation in clinical stage II/III ESCC: a phase II study of induction chemotherapy with docetaxel, cisplatin and 5-FU (DCF) followed by chemoradiotherapy

Authors [No authors listed]
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
Links
INTERVENTION: DCF therapy after 2 course followed by tumor assessment. + DCF therapy 1 course + Chemoradiotherapy 2 course +‐ Salvage surgery + DCF therapy 1 course + Surgery + Surgery [DCF therapy] Docetaxel 75 mg/m2 day1 Cisplatin 75 mg/m2 day1 Fluorouracil 750 mg/m2 day1‐5 Every 3 weeks [Chemoradiotherapy] Fluorouracil 750 mg/m2 day1‐4 Cisplatin 75 mg/m2 day1 Every 4 weeks RT 50.4Gy CONDITION: esophageal cancer PRIMARY OUTCOME: Progression free survival (PFS) at 1 year in patients who were treated with chemoradiotherapy SECONDARY OUTCOME: 1) In all patients, Overall survival (OS) at 1 year and 3 years, PFS at 1 year and 3 years, Esophagectomy free survival.; ; 2) In patients who were treated with chemoradiotherapy, OS at 1 year and 3 years, PFS at 3 year, Complete response rate, Treatment completion rate, Adverse events(AEs).; ; 3) In surgical patients, OS at 1 year and 3 years, PFS at 1 year and 3 years, ; Curative resection rate, AEs.; ; 4) Response rate of DCF therapy, AEs. INCLUSION CRITERIA: 1) Diagnosed squamous cell carcinoma by endoscopic biopsy. 2) Confirmed the lesion of thoracic esophagus (An accessory lesion of EMR absolute criteria may not be localized thoracic esophagus). 3) Clinical stage II/III without T4 in TNM classification (UICC 6th). 4) Age more than 20years and less than 75 years. 5) PS(ECOG) of 0 or 1. 6) No previous treatment expect endoscopic resection of esophageal cancer. 7) No previous chemotherapy or radiation therapy for other malignancy. 8) No severe organ failure. 9) Possibility of transthoracic and/or transabdominal curative resection of esophageal cancer. 10) Signed informed consent of the patient for the registration.
Epistemonikos ID: ac1d4849685b3f1f6471287d08a5d334902fb63f
First added on: Aug 22, 2024