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

Esophageal Cancer Stage III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03366883
• Other study ID #: TianjinCIH20171114
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 14, 2017
• Last updated: January 7, 2018
• Start date: February 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2017
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Yi Ba, MD,PHD
• Phone: +8618622221230
• Email: bayi[@]tjmuch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: December 31, 2022
• Est. primary completion date: February 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer Stage IIB
• Esophageal Cancer Stage III
• Esophageal Neoplasms

Intervention

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)

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)

Locations

Country	Name	City	State
China	TianjinCIH	Tianjin	Tianjin

Sponsors (6)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	First Affiliated Hospital of Chongqing Medical University, Henan Cancer Hospital, Shanghai Chest Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		3 years
Secondary	Disease Free Survival		3years
Secondary	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
Secondary	Objective Response Rate		up to 24 weeks
Secondary	Rate of R0 resection		up to 24 weeks