NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180380

Registered date:19/03/2019

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.

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedProblem(s) Studied
Date of first enrollment05/07/2012
Target sample size100
Countries of recruitment
Study typeInterventional
Intervention(s)DCF therapy after 2 course followed by tumor assessment. <Remarkable response> + DCF therapy 1 course + Chemoradiotherapy 2 course +- Salvage surgery <Limited partial response> + DCF therapy 1 course + Surgery <Poor response> + 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

Outcome(s)

Primary OutcomeProgression free survival (PFS) at 1 year in patients who were treated with chemoradiotherapy
Secondary Outcome1) 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.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 75age old
GenderBoth
Include criteria1) 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.
Exclude criteria1) An active malignancy other than carcinoma in situ or mucosal carcinoma or a history of other malignancy within the past 5 years. 2) Women who are pregnant, lactating, or wish to become pregnant. 3) Unsuitable mental status and condition for clinical trials. 4) Received continuous steroids (orally or intravenous) administration. 5) Positive HBs antigen. 6) Unstable diabetes mellitus with oral hypoglycemic agent or insulin. 7) Acute myocardial infarction within the past 3 months. 8) Severe complications (COPD, interstitial lung disease, pulmonary fibrosis, heart failure and so on) . 9) Active bacterial or fungous infection(body temperature more than 38.5 degrees and proved bacterial infection by diagnostic imaging or bacteriological examination ) . 10) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Related Information

Contact

Public contact
Name Akinori Watanabe
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa Kanagawa Japan 252-0374
Telephone +81-42-778-8111
E-mail akinori@kitasato-u.ac.jp
Affiliation Kitasato University Hospital
Scientific contact
Name Akinori Watanabe
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa Kanagawa Japan 227-0374
Telephone +81-42-778-8111
E-mail akinori@kitasato-u.ac.jp
Affiliation Kitasato University Hospital