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

Esophageal Cancer Clinical Trial

Official title:

Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00686114
• Other study ID #: Shixiu - 1
• Status: Recruiting
• Phase: Phase 3
• First received: May 27, 2008
• Last updated: April 28, 2014
• Start date: May 2008
• Est. completion date: December 2014

Study information

• Verified date: April 2014
• Source: Wenzhou Medical University
• Contact: Shixiu Wu, MD
• Phone: 86-0577-8806-9372
• Email: wushixiu[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 344
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Paclitaxel
135mg/m2, day 1 and day 29 of the radiotherapy.
• Cisplatin
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
• Tarceva
150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)

Radiation:
• Radiotherapy
Enlarged field radiotherapy
• Radiotherapy
Conventional field radiotherapy

Locations

Country	Name	City	State
China	1st affliated hospital of Wen Zhou Medical college	Wen Zhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	failure: death from any cause	five years after enrollment	No
Secondary	Progression-free survival	Failure: occurrence of local or regional progression, distant metastases, or death from any cause	five years after enrollment	No
Secondary	local-regional control rate	Failure: occurrence of local or regional progression	three years after enrollment	No
Secondary	Adverse events	assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema	five years after enrollment	Yes
Secondary	Health-related quality of life	assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)	five years after enrollment	No