Efficacy and Safety of TPF Induction Chemotherapy for Borderline-resectable Esophageal Squamous Cell Carcinoma

NCT02976909 | Completed Phase 2 DMC

• 1 other identifier: TPF-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies the efficacy and safty of paclitaxel in combination with cisplatin and 5-fluorouracil(TPF) induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  The rate of R0 resection

  following resection for up to 36 months

Secondary Outcomes (4)

• pathologic complete response rate

  following resection for up to 36 months

• OS

  for up to 36 months

• PFS

  for up to 36 months

• Adverse envents

  for up to 12 months

Study Arms (1)

Paclitaxel+Cisplatin+5fluorouracil

EXPERIMENTAL

Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.

Drug: Paclitaxel+Cisplatin+5fluorouracil

Interventions

Paclitaxel+Cisplatin+5fluorouracil DRUG

Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.

Also known as: Paclitaxel, Cisplatin, 5fluorouracil

Paclitaxel+Cisplatin+5fluorouracil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should be voluntary to the trial and provide with signed informed consent.
• Male or female patients, age:18-70 years old
• Confirmed by histology of thoracic esophageal squamous cell carcinoma without metastasis and diagnosed as boundary resectable by Multidisciplinary consultation, including cT4 and/or bulky lymphadenopathy that may invade nearby organs(such as the great vessels, trachea and heart, etc.)
• Measurable or unmeasurable lesions according the RECIST 1.1 criteria.
• No previous chemotherapy or radiotherapy.
• Life expectancy ≥ 3 months.
• ECOG PS 0-1.
• Blood routine within 7 days：Hb ≥9g/L，NE ≥1.5×109/L，PLT ≥100×109/L；
• Hepatic and renal function：TB \<1.5 UNL， Cr\< 1.5× UNL， AST / ALT \< 2.5× UNL， ALP \< 5.0 × UNL。
• No severe complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever \> 38 ℃
• Fertile patients should take effective contraceptive measures.
• Patients should have good compliance and cooperate with the evaluation of efficacy and adverse events and follow-ups according to the research plan.

You may not qualify if:

• Cervical esophageal carcinoma.
• Known severe hypersensitivity to drugs in the regimen.
• Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).
• Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.
• Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
• Evidence of active infection or active epidemic disease.
• Psychiatric illness that would prevent the patient from giving informed consent
• Pregnant or lactating women.

Sponsors & Collaborators

• Yuhong Li: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (2)

• Wu JD, Wang ZQ, Li QQ, Li ZC, Ren C, Wang DS, Chen JY, Tan Q, Li YH, Yang H. A 3-Year Survival Update from a Phase 2 Study of Paclitaxel Plus Cisplatin and 5-Fuorouracil Induction Chemotherapy for Locally Advanced Borderline-Resectable Esophageal Squamous Cell Carcinoma: The NEOCRTEC-1601 Clinical Trial. Ann Surg Oncol. 2024 Feb;31(2):838-846. doi: 10.1245/s10434-023-14513-0. Epub 2023 Nov 2.

  PMID: 37919448 DERIVED

• Wang Z, Hu M, Hu Y, Li Q, Wu J, Fong WP, Ren C, Wang D, Tan Q, Yang H, Li Y. Paclitaxel plus cisplatin and 5-fluorouracil induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma: a phase II clinical trial. Esophagus. 2022 Jan;19(1):120-128. doi: 10.1007/s10388-021-00864-8. Epub 2021 Jul 28.

  PMID: 34319435 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Paclitaxel; Cisplatin; Fluorouracil

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yu-hong Li, MD, Ph D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

CN (1)