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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02461043
Other study ID # CH-GI-046
Secondary ID
Status Recruiting
Phase Phase 3
First received May 30, 2015
Last updated August 29, 2015
Start date April 2015
Est. completion date December 2023

Study information

Verified date August 2015
Source Chinese Academy of Medical Sciences
Contact Jing Huang
Phone 8610-87788102
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

- Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.

- No standard postoperative adjuvant chemotherapy has ever been established.


Recruitment information / eligibility

Status Recruiting
Enrollment 386
Est. completion date December 2023
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ability to give informed consent

- histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins

- node-positive and pathologic stage M0

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Patients were enrolled 4 to 10 weeks after surgery

- Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) =60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits

Exclusion Criteria:

- prior chemotherapy or concurrent radiation therapy before esophagectomy

- R1 or R2 resection

- clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination

Study Design

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


Intervention

Drug:
paclitaxel; cisplatin
The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.
Radiation:
radiation
radiation

Locations

Country Name City State
China Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 5 year overall survival 8 years Yes
Primary 3 year relapse free survival 5 years Yes
Secondary 3 year overall survival 5 years Yes
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