A study of the safety and efficacy of synbiotic treatment in patients with thoracic esophageal cancer who received DCF (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant chemotherapy (NAC) during the perioperative period.

A study of the safety and efficacy of synbiotic treatment in patients with thoracic esophageal cancer who received DCF (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant chemotherapy (NAC) during the perioperative period. - Safety and efficacy of synbiotic treatment in patients with thoracic esophageal cancer who received DCF as neoadjuvant chemotherapy (NAC).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013999

Enrollment

Registered

2014-05-19

Start date

2014-04-21

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

thoracic esophageal cancer

Interventions

During NAC period and the perioperative period, take in Bio-Three 3 gram and GFO 3 packs to a meal three times a day. Synbiotic treatment during NAC:oral intake,Bio-Three ( Streptococcus faecalis, Cl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Thoracic esophageal cancer who received DCF therapy for neoadjuvant chemotherapy. 2.R0 esophagectomy is judged as possible by thoracotomy (or thoracoscopic surgery) and laparotomy (or laparoscopic surgery). 3.Bio-Three and GFO intake is possible. 4.ECOG<2. 5.Adequate organ functions. 6.Written informed consent.

Exclusion criteria

Exclusion criteria: 1.Simultaneous or metachonous double cancers. 2.Uncontrolled active infectious disease requiring systemic treatment. 3.Positive HBs antigen, HCV antibody or HIV antibody. 4.Pregnant or women of childbearing potential 5.Patients requiring systemic administration of steroids. 6.Uncontrolled psychiatric disease. 7.History of myocardial infarction within 6 months or unstable angina. 8.Severe emphysema or pulmonary fibrosis. 9.Diabetes mellitus with HbA1c of 8.0% or higher. 10.Physician judgment disqualified.

Design outcomes

Primary

Measure	Time frame
Probability of more than grade3 oral mucosal damage during NAC.	—

Secondary

Measure	Time frame
(1)Febrile neutropenia,(2)Adverse event occurrence rate,(3)Postoperative infectious complication,(4)Perioperative complication,(5)Duration of SIRS,(6)Duration of ICU admission,(7)Postoperative length of stay,(8)Clinical response rate,(9)Pathological complete response	—

Countries

Japan

Contacts

Public ContactRyosuke Kawai

Aichi Cancer Center Central Hospital Department of Gastroenterological Surgery

rkawai@aichi-cc.jp052-762-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026