Text Size

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

This study is currently recruiting participants.
Verified August 2012 by Wenzhou Medical College
Sponsor:
Information provided by (Responsible Party):
Wu Shixiu, Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT00686114
First received: May 27, 2008
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  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: Parallel 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:

U.S. FDA Resources

Further study details as provided by Wenzhou Medical College:

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 NCI CTCAE v3.0

  • 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: 325
Study Start Date: May 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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 3 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 ≥ 100 g/L; serum Cr ≤ ULN; serum bilirubin ≤ ULN; ALT/AST ≤ 2.5ULN
  6. Subjects should sign for the informed consent
  7. Subjects should perform good compliance
  8. 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 uncontrolled infection or severe medical disease
  2. Patient who used to appear 4th stage swallowing obstruction or perforation/symptomatic-perforation after radiotherapy
  3. Patients who are/were given any other medicine tests currently/in last 4 weeks
  4. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
  5. Women in status of pregnancy
  6. Patients with main organ failure
  7. Other kinds of abnormal, e.g: mental anomaly, drug abuse, alcohol abuse, and such so on, with which will not fit for this study.
  Contacts and Locations
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, Zhe Jiang Province
1st affliated hospital of Wen Zhou Medical college Recruiting
Wen Zhou City, Zhe Jiang Province, 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 College
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 College
ClinicalTrials.gov Identifier: NCT00686114     History of Changes
Other Study ID Numbers: Shixiu - 1
Study First Received: May 27, 2008
Last Updated: August 21, 2012
Health Authority: China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013