Paclitaxel, Cisplatin,5-FU vs. Radiotherapy Plus Paclitaxel, Cisplatin as Preoperative Therapy for Locally Advanced ESC

Phase 3

• Conditions: Esophageal Cancer Stage IIB; Esophageal Cancer Stage III
• Interventions: Combination Product: Paclitaxel, Cisplatin Plus 5-FU (TCF); Radiation: radiochemotherapy

• Registration Number: NCT03366883
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

This is a Phase III clinical trail which Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy with Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer. The Preoperative chemoradiotherapy with radical surgery is the standard treatment in China. But, many patients do not receive this treatment for many other reasons. Most of them refused or abandon radiotherapy because of the Intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of TCF over chemoradiotherapy with TC (TC-RT) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-08
• Last Update Submitted: 2018-01-07
• Last Update Posted: 2018-01-09
• Study Start: 2018-02-01
• Primary Completion: 2018-02-04
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Histologically proven squamous cell carcinoma.
• All lesions are located in the thoracic esophagus.
• Clinical stages IIB and III (excluding T4) based on the 7th UICC-TNM classification.
• 20-75 years old.
• ECOG performance status of 0 or 1.
• Measurable lesions not required.
• No prior therapy against esophageal cancer except for complete resection by endoscopic mucosal resection/endoscopic submucosal dissection with either pM1/M2 disease or pM3 disease without vascular infiltration.
• No prior chemotherapy, radiotherapy or hormonal therapy against any cancers
• Adequate organ function.
• Written informed consent.

Exclusion Criteria

• Synchronous or metachronous double cancers, except for intramucosal tumor curatively resected by local therapy.
• Active infection requiring systemic therapy
• Positive hepatitis B surface antigen and hepatitis B core antigen or human immunodeficiency virus antibody.(only positive hepatitis B surface antigen should receive anti-virus treatment during study)
• Pregnant or lactating women or women of childbearing potential.
• Patients requiring systemic steroid medication.
• Iodine hypersensitivity.
• Psychiatric disease.
• Hypersensitivity for CremophorEL.
• Poorly controlled diabetes.
• Severe emphysema or pulmonary fibrosis.
• Poorly controlled hypertension.
• Unstable angina within 3 weeks or with a history of myocardial infarction within 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Paclitaxel, Cisplatin Plus 5-FU (TCF)	Paclitaxel, Cisplatin Plus 5-FU (TCF)	preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks
Preoperative radiochemotherapy	radiochemotherapy	preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week

Primary Outcome Measures

Name	Time	Method
Overall Survival	3 years

Secondary Outcome Measures

Name	Time	Method
Rate of R0 resection	up to 24 weeks
Disease Free Survival	3years
Objective Response Rate	up to 24 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	through study completion, an average of 1 year	All participants with treatment-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (1)

TianjinCIH; 🇨🇳 Tianjin, Tianjin, China