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

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ClinicalTrials.gov Identifier: NCT00686114
Recruitment Status : Unknown
Verified April 2014 by Wu Shixiu, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : May 29, 2008
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Wu Shixiu, Wenzhou Medical University

Tracking Information
First Submitted Date  ICMJE May 27, 2008
First Posted Date  ICMJE May 29, 2008
Last Update Posted Date April 29, 2014
Study Start Date  ICMJE May 2008
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2012)
overall survival [ Time Frame: five years after enrollment ]
failure: death from any cause
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
blood routine examination [ Time Frame: twice a week ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
  • Progression-free survival [ Time Frame: five years after enrollment ]
    Failure: occurrence of local or regional progression, distant metastases, or death from any cause
  • local-regional control rate [ Time Frame: three years after enrollment ]
    Failure: occurrence of local or regional progression
  • Adverse events [ Time Frame: five years after enrollment ]
    assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema
  • Health-related quality of life [ Time Frame: five years after enrollment ]
    assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2008)
  • blood biochemistry test [ Time Frame: in 3 days before every beginning of course ]
  • follow-up visit for safety [ Time Frame: in 30 days after last dosage ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer
Official Title  ICMJE Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE
  • 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 Name: Erlotinib Hydrochloride Tablets
  • Radiation: Radiotherapy
    Enlarged field radiotherapy
  • Radiation: Radiotherapy
    Conventional field radiotherapy
Study Arms  ICMJE
  • Experimental: A
    Enlarged field + Paclitaxel + Cisplatin + Tarceva
    Interventions:
    • Drug: Paclitaxel
    • Drug: Cisplatin
    • Drug: Tarceva
    • Radiation: Radiotherapy
  • Experimental: B
    Enlarged field + Paclitaxel + Cisplatin
    Interventions:
    • Drug: Paclitaxel
    • Drug: Cisplatin
    • Radiation: Radiotherapy
  • Active Comparator: C
    Conventional field + Paclitaxel + Cisplatin + Tarceva
    Interventions:
    • Drug: Paclitaxel
    • Drug: Cisplatin
    • Drug: Tarceva
    • Radiation: Radiotherapy
  • Active Comparator: D
    Conventional field + Paclitaxel + Cisplatin
    Interventions:
    • Drug: Paclitaxel
    • Drug: Cisplatin
    • Radiation: Radiotherapy
Publications * 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 Sep 22. doi: 10.1038/s41416-020-01054-6. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 28, 2014)
344
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2008)
300
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00686114
Other Study ID Numbers  ICMJE Shixiu - 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wu Shixiu, Wenzhou Medical University
Study Sponsor  ICMJE Wenzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shixiu Wu, MD 1st affliated hospital of Wen Zhou Medical college
PRS Account Wenzhou Medical University
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP