Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer - Full Text View

Sponsored by:	Wenzhou Medical College
Information provided by:	Wenzhou Medical College
ClinicalTrials.gov Identifier:	NCT00686114

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	Phase III

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

Drug Information available for: Cisplatin Paclitaxel Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Caregiver), Placebo Control, Parallel Assignment, Bio-equivalence Study
Official Title:	Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-Center Trial.

Further study details as provided by Wenzhou Medical College:

Primary Outcome Measures:

blood routine examination [ Time Frame: twice a week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

blood biochemistry test [ Time Frame: in 3 days before every beginning of course ] [ Designated as safety issue: No ]
follow-up visit for safety [ Time Frame: in 30 days after last dosage ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
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
A: Experimental Enlarged field + Paclitaxel + Cisplatin + Tarceva	Drug: Paclitaxel 135mg/m2,IV,a 28days cycle start on day 1 and day 29 from the beginning of radiotherapy. Drug: Cisplatin 135mg/m2,IV,a 28days cycle start on day 1 and day 29 from the beginning of radiotherapy. Drug: Tarceva 150mg/per day,oral administration, from day 1 to day 42 (after the beginning of therapy)
B: Experimental Enlarged field + Paclitaxel + Cisplatin	Drug: Paclitaxel 135mg/m2,IV,a 28days cycle start on day 1 and day 29 from the beginning of radiotherapy. Drug: Cisplatin 135mg/m2,IV,a 28days cycle start on day 1 and day 29 from the beginning of radiotherapy.
C: Active Comparator Conformal field + Paclitaxel + Cisplatin + Tarceva	Drug: Paclitaxel 135mg/m2,IV,a 28days cycle start on day 1 and day 29 from the beginning of radiotherapy. Drug: Cisplatin 135mg/m2,IV,a 28days cycle start on day 1 and day 29 from the beginning of radiotherapy. Drug: Tarceva 150mg/per day,oral administration, from day 1 to day 42 (after the beginning of therapy)
D: Active Comparator Conformal field + Paclitaxel + Cisplatin	Drug: Paclitaxel 135mg/m2,IV,a 28days cycle start on day 1 and day 29 from the beginning of radiotherapy. Drug: Cisplatin 135mg/m2,IV,a 28days cycle start on day 1 and day 29 from the beginning of 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 approach the therapeutic effect for this method in 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:

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 3 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 ≥ 100 g/L; serum Cr ≤ ULN; serum bilirubin ≤ ULN; ALT/AST ≤ 2.5ULN
Subjects should sign for the informed consent
Subjects should perform good compliance
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 uncontrolled infection or severe medical disease
Patient who used to appear 4th stage swallowing obstruction or perforation/symptomatic-perforation after radiotherapy
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 lactation or gestation
Patients with main organ failure
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
Wen Zhou City, Zhe Jiang Province, China, 325000

Sponsors and Collaborators

Wenzhou Medical College

Investigators

Principal Investigator:

Shixiu Wu, MD

1st affliated hospital of Wen Zhou Medical college

More Information

Responsible Party:	the first affilated hospital of Wenzhou Medical College ( Li Gang )
Study ID Numbers:	Shixiu - 1
Study First Received:	May 27, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00686114
Health Authority:	China: Ministry of Health

Keywords provided by Wenzhou Medical College:

CR
PR
NC
PD
Survival

Study placed in the following topic categories:

Erlotinib
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Carcinoma
Digestive System Diseases

Cisplatin
Paclitaxel
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Protein Kinase Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009