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Trial Title:
Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer
NCT ID:
NCT00686114
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Paclitaxel
Erlotinib Hydrochloride
Conditions: Keywords:
Esophageal cancer
chemoradiation
radiosensitivity
EGFR inhibition
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
135mg/m2, day 1 and day 29 of the radiotherapy.
Arm group label:
A
Arm group label:
B
Arm group label:
C
Arm group label:
D
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
Arm group label:
A
Arm group label:
B
Arm group label:
C
Arm group label:
D
Intervention type:
Drug
Intervention name:
Tarceva
Description:
150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)
Arm group label:
A
Arm group label:
C
Other name:
Erlotinib Hydrochloride Tablets
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Enlarged field radiotherapy
Arm group label:
A
Arm group label:
B
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Conventional field radiotherapy
Arm group label:
C
Arm group label:
D
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
1st affliated hospital of Wen Zhou Medical college
Address:
City:
Wen Zhou
Zip:
325000
Country:
China
Status:
Recruiting
Contact:
Last name:
Shixiu Wu, M.D.
Phone:
+86057788069372
Email:
wushixiu@medmail.com.cn
Contact backup:
Last name:
Xuebang Zhang, M.D.
Email:
baxuza@126.com
Investigator:
Last name:
Shixiu Wu, MD
Email:
Principal Investigator
Start date:
May 2008
Completion date:
December 2014
Lead sponsor:
Agency:
Wenzhou Medical University
Agency class:
Other
Source:
Wenzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00686114
