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Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Paclitaxel

Cisplatin

Tarceva

Radiotherapy

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, chemoradiation, radiosensitivity, EGFR inhibition

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must be confirmed Esophageal Carcinoma pathologically
(EUS)I～IVa, without contraindication for radical radiotherapy
Subjects haven't been given neither radiotherapy nor chemotherapy before
Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
Subjects should sign for the informed consent
Subjects should perform good compliance
Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative.

Exclusion Criteria:

Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
Complete obstruction of the esophagus, or patients who have the potential to develop perforation
Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
Patients who multiple foci esophagus
Patients who are/were given any other medicine tests currently/in last 4 weeks
Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
Women in status of pregnancy
Patients who have complications exist as following:

(1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness

Sites / Locations

1st affliated hospital of Wen Zhou Medical collegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Enlarged field + Paclitaxel + Cisplatin + Tarceva

Enlarged field + Paclitaxel + Cisplatin

Conventional field + Paclitaxel + Cisplatin + Tarceva

Conventional field + Paclitaxel + Cisplatin

Outcomes

Primary Outcome Measures

overall survival

failure: death from any cause

Secondary Outcome Measures

Progression-free survival

Failure: occurrence of local or regional progression, distant metastases, or death from any cause

local-regional control rate

Failure: occurrence of local or regional progression

Adverse events

assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema

Health-related quality of life

assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)

Full Information

NCT ID

NCT00686114

First Posted

May 27, 2008

Last Updated

April 28, 2014

Sponsor

Wenzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00686114

Brief Title

Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

Official Title

Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2008 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wenzhou Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.

Detailed Description

For the esophageal carcinoma in II~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.

6. Conditions and Keywords

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

Esophageal Cancer

Keywords

Esophageal cancer, chemoradiation, radiosensitivity, EGFR inhibition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

344 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Enlarged field + Paclitaxel + Cisplatin + Tarceva

Arm Title

Arm Type

Experimental

Arm Description

Enlarged field + Paclitaxel + Cisplatin

Arm Title

Arm Type

Active Comparator

Arm Description

Conventional field + Paclitaxel + Cisplatin + Tarceva

Arm Title

Arm Type

Active Comparator

Arm Description

Conventional field + Paclitaxel + Cisplatin

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

135mg/m2, day 1 and day 29 of the radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Tarceva

Other Intervention Name(s)

Erlotinib Hydrochloride Tablets

Intervention Description

150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Enlarged field radiotherapy

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Conventional field radiotherapy

Primary Outcome Measure Information:

Title

overall survival

Description

failure: death from any cause

Time Frame

five years after enrollment

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Failure: occurrence of local or regional progression, distant metastases, or death from any cause

Time Frame

five years after enrollment

Title

local-regional control rate

Description

Failure: occurrence of local or regional progression

Time Frame

three years after enrollment

Title

Adverse events

Description

assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema

Time Frame

five years after enrollment

Title

Health-related quality of life

Description

assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)

Time Frame

five years after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects must be confirmed Esophageal Carcinoma pathologically (EUS)I～IVa, without contraindication for radical radiotherapy Subjects haven't been given neither radiotherapy nor chemotherapy before Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN Subjects should sign for the informed consent Subjects should perform good compliance Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative. Exclusion Criteria: Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy Complete obstruction of the esophagus, or patients who have the potential to develop perforation Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years Patients who multiple foci esophagus Patients who are/were given any other medicine tests currently/in last 4 weeks Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines Women in status of pregnancy Patients who have complications exist as following: (1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness

Central Contact Person:

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

Shixiu Wu, MD

Phone

86-0577-8806-9372

wushixiu@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shixiu Wu, MD

Organizational Affiliation

1st affliated hospital of Wen Zhou Medical college

Official's Role

Principal Investigator

Facility Information:

Facility Name

1st affliated hospital of Wen Zhou Medical college

City

Wen Zhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shixiu Wu, M.D.

Phone

+86057788069372

wushixiu@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Xuebang Zhang, M.D.

baxuza@126.com

First Name & Middle Initial & Last Name & Degree

Shixiu Wu, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

32958820

Citation

Xie C, Jing Z, Luo H, Jiang W, Ma L, Hu W, Zheng A, Li D, Ding L, Zhang H, Xie C, Lian X, Du D, Chen M, Bian X, Tan B, Xia B, Xie R, Liu Q, Wang L, Wu S. Chemoradiotherapy with extended nodal irradiation and/or erlotinib in locally advanced oesophageal squamous cell cancer: long-term update of a randomised phase 3 trial. Br J Cancer. 2020 Nov;123(11):1616-1624. doi: 10.1038/s41416-020-01054-6. Epub 2020 Sep 22.

Results Reference

derived

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Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer

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