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

Phase 2

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Paclitaxel+Cisplatin+5fluorouracil

• Registration Number: NCT02976909
• Lead Sponsor: Yuhong Li

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-29
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Patients should be voluntary to the trial and provide with signed informed consent.
2. Male or female patients, age:18-70 years old
3. 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.)
4. Measurable or unmeasurable lesions according the RECIST 1.1 criteria.
5. No previous chemotherapy or radiotherapy.
6. Life expectancy ≥ 3 months.
7. ECOG PS 0-1.
8. Blood routine within 7 days：Hb ≥9g/L，NE ≥1.5×109/L，PLT ≥100×109/L；
9. Hepatic and renal function：TB <1.5 UNL， Cr< 1.5× UNL， AST / ALT < 2.5× UNL， ALP < 5.0 × UNL。
10. No severe complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever > 38 ℃
11. Fertile patients should take effective contraceptive measures.
12. 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

1. Cervical esophageal carcinoma.
2. Known severe hypersensitivity to drugs in the regimen.
3. 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).
4. 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.
5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
6. Evidence of active infection or active epidemic disease.
7. Psychiatric illness that would prevent the patient from giving informed consent
8. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel+Cisplatin+5fluorouracil	Paclitaxel+Cisplatin+5fluorouracil	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.

Primary Outcome Measures

Name	Time	Method
R0 resection rate	following resection for up to 36 months	The rate of R0 resection

Secondary Outcome Measures

Name	Time	Method
OS	for up to 36 months	the duration from enrollment to the patient's death (all causes)
PFS	for up to 36 months	the duration from enrollment to tumour progression or the patient's death (all causes) (whichever comes first)
Adverse envents	for up to 12 months	Incidence of AEs and SAEs during the study.
pathologic complete response rate	following resection for up to 36 months	The rate of pathologic complete response following surgery

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China