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.

JRCT ID: jRCTs031180380

Registered date:19/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Problem(s) Studied
• Date of first enrollment: 05/07/2012
• Target sample size: 100
• Study type: Interventional

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 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude criteria

1) 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

• Primary Sponsor: Watanabe Akinori
• Secondary Sponsor: Tahara Makoto,Yakult Honsha Co., Ltd.
• Secondary ID(s): 8086