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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Wenzhou Medical University
Sponsor:
Information provided by (Responsible Party):
Wu Shixiu, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT00686114
First received: May 27, 2008
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Drug: Paclitaxel
Drug: Cisplatin
Drug: Tarceva
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.

Resource links provided by NLM:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • overall survival [ Time Frame: five years after enrollment ] [ Designated as safety issue: No ]
    failure: death from any cause


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: five years after enrollment ] [ Designated as safety issue: No ]
    Failure: occurrence of local or regional progression, distant metastases, or death from any cause

  • local-regional control rate [ Time Frame: three years after enrollment ] [ Designated as safety issue: No ]
    Failure: occurrence of local or regional progression

  • Adverse events [ Time Frame: five years after enrollment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)


Estimated Enrollment: 344
Study Start Date: May 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Erlotinib Hydrochloride Tablets
Radiation: Radiotherapy
Enlarged 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
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 Name: Erlotinib Hydrochloride Tablets
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
Conventional field radiotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686114

Contacts
Contact: Shixiu Wu, MD 86-0577-8806-9372 wushixiu@medmail.com.cn

Locations
China, Zhejiang
1st affliated hospital of Wen Zhou Medical college Recruiting
Wen Zhou, Zhejiang, China, 325000
Contact: Shixiu Wu, M.D.    +86057788069372    wushixiu@medmail.com.cn   
Contact: Xuebang Zhang, M.D.       baxuza@126.com   
Principal Investigator: Shixiu Wu, MD         
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: Shixiu Wu, MD 1st affliated hospital of Wen Zhou Medical college
  More Information

No publications provided

Responsible Party: Wu Shixiu, Professor, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT00686114     History of Changes
Other Study ID Numbers: Shixiu - 1
Study First Received: May 27, 2008
Last Updated: April 28, 2014
Health Authority: China: Ministry of Health

Keywords provided by Wenzhou Medical University:
Esophageal cancer
chemoradiation
radiosensitivity
EGFR inhibition

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Cisplatin
Erlotinib
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014