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

NCT03366883 | Unknown Phase 3

• 1 other identifier: TianjinCIH20171114
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer Stage IIB; Esophageal Cancer Stage III

Keywords

preoperative chemotherapy; preoperative chemoradiotherapy; clinical trial; phase III; Esophageal squamous cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  3 years

Secondary Outcomes (4)

• Disease Free Survival

  3years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  through study completion, an average of 1 year

• Objective Response Rate

  up to 24 weeks

• Rate of R0 resection

  up to 24 weeks

Study Arms (2)

"Paclitaxel, Cisplatin Plus 5-FU (TCF)

EXPERIMENTAL

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 radiochemotherapy

EXPERIMENTAL

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

Interventions

Paclitaxel, Cisplatin Plus 5-FU (TCF) COMBINATION_PRODUCT

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)

"Paclitaxel, Cisplatin Plus 5-FU (TCF)

radiochemotherapy RADIATION

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)

Preoperative radiochemotherapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

TianjinCIH

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel; Cisplatin; Fluorouracil; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Yi Ba, MD,PHD

CONTACT

+8618622221230; bayi@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 8, 2017
• Study Start: February 1, 2018
• Primary Completion: February 4, 2018
• Study Completion: December 31, 2022
• Last Updated: January 9, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)