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

April 28, 2014 updated by: Wu Shixiu, Wenzhou Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

344

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wen Zhou, Zhejiang, China, 325000
        • Recruiting
        • 1st affliated hospital of Wen Zhou Medical college
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shixiu Wu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects must be confirmed Esophageal Carcinoma pathologically
  2. (EUS)I～IVa, without contraindication for radical radiotherapy
  3. Subjects haven't been given neither radiotherapy nor chemotherapy before
  4. Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
  5. 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
  6. Subjects should sign for the informed consent
  7. Subjects should perform good compliance
  8. 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:

  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
  2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation
  3. 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
  4. Patients who multiple foci esophagus
  5. Patients who are/were given any other medicine tests currently/in last 4 weeks
  6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
  7. Women in status of pregnancy
  8. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Enlarged field + Paclitaxel + Cisplatin + Tarceva
Drug: Paclitaxel
135mg/m2, day 1 and day 29 of the radiotherapy.
Drug: Cisplatin
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
Drug: Tarceva
150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)
Other Names:
  • Erlotinib Hydrochloride Tablets
Radiation: Radiotherapy
Enlarged field radiotherapy
Radiation: Radiotherapy
Conventional field radiotherapy
EXPERIMENTAL: B
Enlarged field + Paclitaxel + Cisplatin
Drug: Paclitaxel
135mg/m2, day 1 and day 29 of the radiotherapy.
Drug: Cisplatin
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
Radiation: Radiotherapy
Enlarged field radiotherapy
Radiation: Radiotherapy
Conventional field radiotherapy
ACTIVE_COMPARATOR: C
Conventional field + Paclitaxel + Cisplatin + Tarceva
Drug: Paclitaxel
135mg/m2, day 1 and day 29 of the radiotherapy.
Drug: Cisplatin
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
Drug: Tarceva
150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)
Other Names:
  • Erlotinib Hydrochloride Tablets
Radiation: Radiotherapy
Enlarged field radiotherapy
Radiation: Radiotherapy
Conventional field radiotherapy
ACTIVE_COMPARATOR: D
Conventional field + Paclitaxel + Cisplatin
Drug: Paclitaxel
135mg/m2, day 1 and day 29 of the radiotherapy.
Drug: Cisplatin
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
Radiation: Radiotherapy
Enlarged field radiotherapy
Radiation: Radiotherapy
Conventional field radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: five years after enrollment
failure: death from any cause
five years after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: five years after enrollment
Failure: occurrence of local or regional progression, distant metastases, or death from any cause
five years after enrollment
local-regional control rate
Time Frame: three years after enrollment
Failure: occurrence of local or regional progression
three years after enrollment
Adverse events
Time Frame: five years after enrollment
assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema
five years after enrollment
Health-related quality of life
Time Frame: five years after enrollment
assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)
five years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Principal Investigator: Shixiu Wu, MD, 1st affliated hospital of Wen Zhou Medical college

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (ESTIMATE)

May 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shixiu - 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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