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.

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. - CROC trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180380

Enrollment

100

Registered

2019-03-19

Start date

2012-07-05

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Problem(s) Studied Esophageal squamous cell carcinoma

Interventions

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 7

D060828

Medicine

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS) at 1 year in patients who were treated with chemoradiotherapy	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactAkinori Watanabe

Kitasato University Hospital

akinori@kitasato-u.ac.jp+81-42-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026