Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel

NCT04699994 | Unknown Phase 2

• 1 other identifier: N20190007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Histological response rate (Grade 2 or 3 in Japanese Classification of Esophageal Cancer, 11th Edition)

  2.5 years

Secondary Outcomes (11)

• Response rate

  2.5 years

• Histological complete response rate

  2.5 years

• Treatment completion rate

  2.5 years

• Curative resection rate

  2.5 years

• Recurrence free survival

  4.5 years

Study Arms (1)

FLOT therapy

EXPERIMENTAL

Drug: FLOT therapy

Interventions

FLOT therapy DRUG

Preoperative FLOT therapy

FLOT therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid)
• Primary tumor is located mainly in the thoracic esophagus
• cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1)
• Twenty years old or older as of registration
• Performance status (PS) 0 or 1
• Patients have target lesions
• No previous history of esophageal cancer except for the followings
• \) pT1a-LPM (M2) or deeper following EMR/ESD 2) pT1a-MM (M3) with vascular invasion following EMR/ ESD 8. No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval 9. Patients who meet the following criteria
• Neutrophil \> 1,500 /mm3
• Platelet \> 10.0x10\^4 /mm3
• Hb ≧9.0 g/dL
• Total bilirubin ≦ 1.5 mg/dL
• AST ≦ 100 IU/L
• ALT ≦ 100 IU/L
• SpO2 ≧ 95 %

You may not qualify if:

• Patients who received any treatment for cancer within 3 years
• Patients who have active infectious diseases
• HBs Ag positive or HIV Ab positive
• Pregnant or breast feeding
• Patients with psychological disorder
• On systemic steroid therapy
• Require flucytocine, phenytoin, warfarin
• Allergic to iodine
• Allergic to DTX, LOHP, polisorbate 80
• Uncontrollable diabetes
• Severe COPD or lung fibrosis
• Severe hypertension
• Unstable angina
• Patients whom investigators evaluate as ineligible

Sponsors & Collaborators

• Keio University: lead

Study Sites (1)

Keio University Hospital

Tokyo, 1608582, Japan

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Satoru Matsuda

CONTACT

+81333531211; s.matsuda.a8@keio.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: June 25, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

JP (1)