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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Paclitaxel+Cisplatin+5fluorouracil

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 lymph node metastasis that may invade nearby organs(such as great vessels,trachea,etc.)
Lesions can be measured 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.

Exclusion Criteria:

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.

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel+Cisplatin+5fluorouracil

Arm Description

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.

Outcomes

Primary Outcome Measures

R0 resection rate

The rate of R0 resection

Secondary Outcome Measures

pathologic complete response rate

The rate of pathologic complete response following surgery

the duration from enrollment to the patient's death (all causes)

PFS

the duration from enrollment to tumour progression or the patient's death (all causes) (whichever comes first)

Adverse envents

Incidence of AEs and SAEs during the study.

Full Information

NCT ID

NCT02976909

First Posted

November 22, 2016

Last Updated

February 14, 2023

Sponsor

Yuhong Li

1. Study Identification

Unique Protocol Identification Number

NCT02976909

Brief Title

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

Official Title

Paclitaxel In Combination With Cisplatin and 5-fluorouracil(TPF) Induction Chemotherapy for Locally Advanced Borderline-resectable Esophageal Squamous Cell Carcinoma: A Phase II Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

December 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Yuhong Li

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Esophageal cancer is one of the most common malignant tumors in China. In Asian countries, esophageal squamous carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous carcinoma is usually poor and surgery is the only radical treatment. However, the optimal therapy pattern for local advanced esophageal carcinoma is still unclear. Part of the patients that clinical staging as T4 and with bulky lymph node metastasis are initially diagnosed as borderline-resectable, which means patients may be able to undergo R0 resection. However, for patients who are diagnosed as borderline-resectable esophageal carcinoma, there are still no sufficient studies implicate that how to improve R0 resection rate by convertion chemotherapy. Cisplatin in combination with 5-FU and docetaxel regimen(DCF) was reported as effective neoadjuvant chemotherapy in treating esophageal squamous carcinoma. However, studies also showed that the DCF regimen caused severe adverse reaction. The mechanism of paclitaxel is similar to docetaxel while with less adverse events than docetaxel. Based on the research situation mentioned above, the investigators decided to conduct a phase II clinical trial to further explore the efficacy and safety of paclitaxel in combination with cisplatin and 5-FU (TPF) induction chemotherapy for locally advanced borderline-resectable esophageal squamous carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel+Cisplatin+5fluorouracil

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel+Cisplatin+5fluorouracil

Other Intervention Name(s)

Paclitaxel, Cisplatin, 5fluorouracil

Intervention Description

Primary Outcome Measure Information:

Title

R0 resection rate

Description

The rate of R0 resection

Time Frame

following resection for up to 36 months

Secondary Outcome Measure Information:

Title

pathologic complete response rate

Description

The rate of pathologic complete response following surgery

Time Frame

following resection for up to 36 months

Title

Description

the duration from enrollment to the patient's death (all causes)

Time Frame

for up to 36 months

Title

PFS

Description

the duration from enrollment to tumour progression or the patient's death (all causes) (whichever comes first)

Time Frame

for up to 36 months

Title

Adverse envents

Description

Incidence of AEs and SAEs during the study.

Time Frame

for up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-hong Li, MD, Ph D

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34319435

Citation

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.

Results Reference

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

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