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

Primary Purpose

Esophageal Cancer Stage IIB, Esophageal Cancer Stage III

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Paclitaxel, Cisplatin Plus 5-FU (TCF)

radiochemotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer Stage IIB focused on measuring preoperative chemotherapy, preoperative chemoradiotherapy, clinical trial, phase III, Esophageal squamous cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

TianjinCIH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

"Paclitaxel, Cisplatin Plus 5-FU (TCF)

Preoperative radiochemotherapy

Arm Description

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 (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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Disease Free Survival

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

All participants with treatment-related adverse events as assessed by CTCAE v4.0

Objective Response Rate

Rate of R0 resection

Full Information

NCT ID

NCT03366883

First Posted

November 14, 2017

Last Updated

January 7, 2018

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Shanghai Chest Hospital, Henan Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Anhui Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03366883

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2018 (Anticipated)

Primary Completion Date

February 4, 2018 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer Stage IIB, Esophageal Cancer Stage III

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

"Paclitaxel, Cisplatin Plus 5-FU (TCF)

Arm Type

Experimental

Arm Description

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

Arm Title

Preoperative radiochemotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Combination Product

Intervention Name(s)

Paclitaxel, Cisplatin Plus 5-FU (TCF)

Intervention Description

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)

Intervention Type

Radiation

Intervention Name(s)

radiochemotherapy

Intervention Description

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 Measure Information:

Title

Overall Survival

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Disease Free Survival

Time Frame

3years

Title

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

Description

All participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

through study completion, an average of 1 year

Title

Objective Response Rate

Time Frame

up to 24 weeks

Title

Rate of R0 resection

Time Frame

up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi Ba, MD,PHD

Phone

+8618622221230

bayi@tjmuch.com

Facility Information:

Facility Name

TianjinCIH

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Contact: