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

A Phase III Trial Comparing Paclitaxel, Cisplatin Plus 5-FU (TCF) Versus Radiotherapy With Paclitaxel Plus Cisplatin (TC-RT) as Preoperative Therapy for Locally Advanced Esophageal Squamous Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer Stage III; Esophageal Cancer Stage IIB
• Intervention / Treatment: Combination product: Paclitaxel, Cisplatin Plus 5-FU (TCF); Radiation: radiochemotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 420
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • TianjinCIH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: "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	Combination product: 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)
EXPERIMENTAL: Preoperative 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	Radiation: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; The First Affiliated Hospital of Anhui Medical University; Henan Cancer Hospital; Shanghai Chest Hospital; First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2018
• Primary Completion (ANTICIPATED): February 4, 2018
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (ACTUAL): December 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 7, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: clinical trial; phase III; preoperative chemotherapy; preoperative chemoradiotherapy; Esophageal squamous cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: TianjinCIH20171114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No